The 10 Most Innovative Medical Devices Companies 2018

1. 1T0HE www.insightscare.com September2018 MOSTINNOVATIVE MEDICALDEVICES COMPANIES 2018 BriannaWronko CEO GroupKDiagnostics: TransformingPatientCarewith Accurate,Fast,&AffordableDiagnostics

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4. Itoday, is old news tomorrow.Thehealthcaresector is no Fromthe Editor nnovation in technology always comes with a promiseof future development possibilities.A new technology launched exception. Technologies like the Internet of Things,Artificial Intelligence, or Additive Manufacturing, have hadtremendous disruptive effects on how we treat patients. They have also influenced the ways we keep track of our healthdaily. AI has brought about a paradigm shift in the healthcare sector, powered by the increased availability of medical data & rapid development of analytics techniques. AI can be useful to process various types of healthcare data, structured and unstructured.Main disease areas that use AI tools consist of cancer, cardiology, and neurology. Diagnostic tools, genetics, electro-diagnosis, monitoring, physiology, disability evaluation, mass screening, and others are some of the prominent subsections that can deploy AI effectively. This technology is largely being used in diagnosis, since its earlydays. “We should think about AI the way we think about patient care-as a continuum, spanning care areas and disease states.”- Dr. Mark Michalski, MD, Executive Director of the Massachusetts General Hospital. AI can use erudite algorithms to ‘learn’ features from anenormous volume of healthcare data, and then use the acquired insights to assist clinical practice. This ability of AI can be further enhanced by equipping it with learning and self-correcting, so as to increase the accuracy of the feedback. An AI based system can assist the physicians; by providing informed medical information from previous literature, and clinical practices, to offer proper patient care. Additionally these systems can help reduce diagnostic and therapeutic errors. All these advantages and assistance is provided in real time, thus providing fast and calculated decisions to the physicians. In spite of AI attracting substantial attention in medical research and healthcare sector, the technology has been facing tangible issues while its implementation. The two major hurdles that AI is currently facing are the regulations that bind the technology, security concerns, and data exchange. The efficacy and safety ofAI systems require standards for their assessment, which current regulations lack. AI based systems require a continuous training or upgrading by clinical studies that are published daily, in order for them to work well. However due to the deficit in data supply and sharing, the initially deployed training with historical data is allthe systems have to offer. Tackling these issues is a must before the healthcare sector can use and unleash the full potential of Artificial Intelligence in providing state-of-the-art patientcare! Artificial Intelligence: Bringing abouta Paradigm Shift in PatientCare Sayaliane Sayali Rane

5. Editor-in-Chief Pooja M. Bansal Managing Editor Ashwini Deshmukh Executive Editors SayaliRane Shane Gomez Contributors Aishwarya,Datta Visualiser DavidKing Art & Design Director AmolKamble Associate Designer RahulKavanekar Co-designer Priyanka,Shweta Art & Picture Editor PaulBelin JayantKhanna Senior Sales Manager AmyJones Business Development Manager MarkWilliams SalesExecutives Kelli Thomas, Bill Thompson, JohnSmith Technical Head SwapnilPatil Technical Specialist Amar, Vivek,Pratiksha Digital Marketing Manager MarryD’Souza SME-SMO Executives Prashant Chevale, Uma Dhenge Research Analyst ChidiebereMoses Circulation Manager Robert, Tanaji Database Management Stella Andrew Technology Consultant DavidStokes sales@insightscare.com September, 2018 CorporateOfces: Insights Success MediaTechLLC 555 Metro Place North,Suite100, Dublin, OH 43017,UnitedStates Phone -(614)-602-1754 Email:info@insightscare.com For Subscription:www.insightscare.com Insights Success Media and Technology Pvt.Ltd. Ofce No. 510, 513, 5th Floor, Rainbow Plaza, Shivar Chowk, Pimple Saudagar, Pune, Maharashtra411017 Phone - India: 7410033802,74100058552 Email:info@insightscare.com For Subscription:www.insightscare.com Copyright © 2018 Insights Success, All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from InsightsSuccess. Reprint rights remain solely with InsightsSuccess.

6. RevolutionaryMedical Devices Transmuting the HealthcareSpace Mprimaryhealthmonitoring,devicesarepresent for everything. edical devices play a decisive role in the healthcare industry. To carry out the smallest of tasks inthis sector, it is important to employ the right device and technology; from a major surgical operationto Medical device companies develop a plethora of products such as wheelchairs, defibrillators, pacemakers, stents, infusion pumps, etc. The medical device industry is highly structured, and companies must continuously invest in research and development in order to preserve a competitive superiority. The future of the global medical device market looks bright with prospects in public and private hospitals. The worldwide medical device arcade isprojected to reach an estimated $409.5 billion by2023. Despite these challenges, medical device companies have always been adept with the latest technology and innovations happening in the sector. Keeping this in mind, we bring you the in-depth profiles of- “The 10Most Innovative Medical Devices Companies 2018.” These 10 are the bellwether medical devices companies, with diverse product ranges, strong performance, and significantrevenues. On the cover we have showcased, Group K Diagnostics. The company manufactures a modular, point-of-care,paper microfluidic diagnostic device with a mobile app that reads the device’s outputs, and quantifies results for physicians to make informed diagnoses within 20 minutes of seeing apatient. Flipping through the pages you will find Motiv Inc. that excels in developing simple wearable devices that canmake people’s lives better; Misceo, is a pioneer that provides cutting-edge real-time cardiac monitoring and analysis for Hospital and clinics; BioSerenity, it is a fast growing company which combines high tech engineering, innovative technologies, medical development, and big data analytics to provide wearable medical device solutions; Trexo Robotics, this company is a pioneer in delivering wearable robotics for children with disabilities to assist with mobility; Zenflow is developing an office-based, less invasive, long lasting, and easy to learn treatment to relievethe symptoms of BPH. We have also featured Oxitone Medical Ltd., Vascular Dynamics, Beyonics, and Lutech Industries; as some ofthe leading medical device manufacturingcompanies. We also bring you an expert’s view on a fiery topic namely ‘AI Is Starting to Change Radiology,’ written byDr. Enhao Gong, who is the founder of SubtleMedical. Our in house editorial team has also put together interesting articles, on trending topics in the healthcarespace. So, flip through the pages of our magazine and treat yourself with the technological innovations trending in the medical deviceindustry!

8. Group K Diagnostics: CoverStay Transforming PatientCare 10 with Accurate, Fast, & AflordableDiagnostics Telemedicine Telemedicine- The Fastest Growing Segment of Emerging Services inHealthcare Industry CXO 2 Transforming Radiology AI is Starting to ChangeRadiology, forReal 38 Organs-On-Chips Organs-On-Chips: A PotentialDrug-testing AlternativeApproach 30

9. tts 18 BioSerenity: Technology at the Service of Healthcare 36 Trexo Robotics: DeliveringFuturistic & Innovative Pediatric Wearable RoboticDevices 20 Misceo Grand Technology: Ushering towards the NextGeneration Telemedicine Technology 26 Motiv: Providing Subtle, Sleek & Sophisticated WearableDevices 42 Zenflow: Driving theFuture of BPH Reliefwith Innovative Solutions

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12. BriannaWronko CEO We provide arevolutionary application ofpoint-of-care diagnostics

13. GroupK Diagnostics: Transforming Patient Carewith Accurate, Fast, & Aflordable Diagnostics

14. CoverStory immunology to design and manufacture Group K’s paper microfluidic devices. Wronko hasa BSE in Bioengineering from the University ofPennsylvania. Her experience with FDA and governmental approval processesfrom her time at Five Eleven Pharma and GSK has been instrumental for streamlining the pre-clinical, clinical, and FDA processes. Now, with a team of research engineers and technicians for device production and development, Wronko focuses on overall technological developmentand companyvision. Discrete Services & Products Group K Diagnostics’ technologyhas two components, hardware and software: The Hardware Component- the paper microfluidic device is designed to support over 60 tests and counting.The design of the devices’ channels,sample deposition region, and detection regions—as well as the instructions for use—remain constant, while the reagents used in the detection regions change to support different diagnostic tests. This allows healthcare providers to learn one protocol for testing instead of having to remember several different ones. The device also features a QR code to note expiration date, test identity, and lot number; a barcode to associate the test with a patient and transmit results to the electronic health record; and a color panel for the computer vision feature of Group K’s mobile app to reference and normalize color based on ambientlighting. The Software Component- iscomprised of several portals targeting various stakeholders in the healthcare system. The mobile app is used to walk the provider through the steps associated with using the device, collect results, inform diagnoses, and record patient data in the Electronic Health System. The flow of the app includes a login page and patient confirmationfollowed T he clinical decisionmaking platform to support those elements. That is when Group K Diagnostics, Inc. was born. Today the companyis working seamlessly under Wronko’s guidance. She serves as the CEO of Group K. Group K manufactures a modular, point-of-care, paper microfluidic diagnostic device with a mobileapp that reads the device’s outputs, and quantifies results for physicians to make informed diagnoses within20 minutes of seeing apatient. The Journey of anIdealistic Organization Group K Diagnostics has developed from a research prototype to a reality. The company foresees bringing to market this transformative technology as early as 2019. Upon the opening of a larger wet lab space, separate manufacturing space, expanded administrative offices, and the completion of initial clinical trial testing by year end 2018, thecompany will begin scaling into the healthcare marketplace. Comprised of aseasoned team of engineers, operators and business executives matched with world class advisors, Group K Diagnostics continues to change the path within the diagnosticsindustry. The Young & Dynamic Leader Wronko brings seven years ofresearch experience in microfluidicsand process is affected by aseries of sequential steps; labtesting being one of the most vital ones.In spite of this, providers are strugglingto effectively receive and manage lab test results, with a significant lag between patient appointments andresults. During her time in a Philadelphia HIV clinic, Brianna Wronko saw a troubling case involving a pregnant mother diagnosed with HIV. Due tothe delay in receiving the patient’s results, the patient remained on her medication, which was detrimental to both her and the fetus. She could not be reached by phone or mail, therefore making a change to her medication impossible until she walked into the clinic several months later. Without the necessary immediate action in response to her test results, the mother and child were left with the possibility of severe physical complications and a high cost of futurecare. This is an extreme case, but such setbacks can be avoided with immediate testing and results. That is when Wronko started working on a product with a thoughtful perceptionof the big picture. She focused on the manufacturing, ease of use, marketability, and adoption in the current healthcare infrastructure, and then scaling the big picture down until she developed the current design,and Our Multi-Diagnostic Point-of-Care test allows providers to takeimmediate therapeutic action based onresults

15. Weofler a paper-baseddiagnostic tool, to cut down the cost of labdiagnosis by image acquisition. A picture of the device’s detection regions is acquired, and through computer vision, image processing, and AI- analysis it produces produce quantified measures that inform diagnoses and are recorded in the EHR. Through the company’s patient app or patient portal login, patients can access their results and transfer them from hospital to hospital. Finally, combining everythingtogether, there is an additional portal availableto hospital administrators. Group K Diagnostics’ hospital portal also has epidemic tracking and hospital preparedness applications with anonymized patient data. By analyzing the type of tests being ordered, and the corresponding results, hospital systems can identify epidemics and better prepare with optimized inventory purchasing and staffing. With big data analysis, Group K Diagnostics can track the severity and geographic location of disease and predict where disease will spread. This information can be used to increase hospital’s preparedness for epidemics andgeneral disease. provider portal organizes the diagnostic tests, and immediately transfers the results to the EHRso information is neverlost. Group K’s technology can be used in specialty and primary care centers.The clinical use of the company’s technology does not impose any additional training on nurses and physicians, so these personnel can easily adopt its technology into their workflow, while eliminating the existing time they spend at the end of their day calling patients or release results to theirpatients. For example, Group K’s Liver Function Test (LFT) results in a measurement for ALT (amongst five other metabolites) in terms of unitsper liter which is used to evaluate one aspect of liver function. The web app would display anonymized data for providers, for example to see if aLiver Clinic was effectively managing medication switches for liver disease patients. The mobile app has patient and provider portals. With 36% of abnormal results never communicated to patients, the app eliminates this miscommunication and allows the patient to have their fulldiagnostictest history stored in their app.The

16. Vision & Mission of Group KDiagnostics Group K Diagnostics offers a clever, simple solution forthe slow, inefficient, and costly laboratory testing that sets today’s standard for 77% of all patient diagnoses. Iterating about Microfluidics in the diagnosis laboratory Wronko says, “We admit that applying microfluidics to the laboratory testing problem is not novel. Research labs have designed and implemented prototypes but fail to make cost effective manufacturing processes and complimentary software.” Group K intends to revolutionize diagnostic testing by having solved the age old problem of adapting microfluidics to laboratory diagnostics by a streamlined, patient and physician suitablediagnostic. Capturing Markets withInnovation Having started out in a strong research vertical, Group K Diagnostics is blazing a new path forward, in point ofcare diagnostic testing. The immediate markets the companyis addressing, include LFTs ($972 million), comprehensive metabolic panels (CMPs, $5.4 billion), and completeblood counts (CBCs, $4.1 billion). The most important facet of Group K’s technology, driving its value, is the time ittakes for diagnostictesting. On average, existing laboratory testing results take 10 days to return to a provider, despite 77% of diagnoses are only completed with lab results. This delay loses patients, transforms acute cases to chronic cases, and increases patient costs. Additionally, this testing procedure costs patients $15-100 per test unless they follow strictinsurance guidelines. The current standard for diagnostic testing and laboratory testing takes too long, during which patients are lost to follow-up, acute cases, can become chronic, thus increasing patientcosts. Relative to the market, Group K Diagnostics is unique in that its product is low cost, requires less than 20 minutesfor

17. results, does not require training or refrigeration, can be completed in office,and supports multiple tests. The company states, “Our biggest competitor- Abbot’s iStat- requires training and refrigeration and cannot be completed inoffice.” Matchless Solution to Point-Of-Care DiagnosticTesting Group K’s technology reduces the time to results from 10 days to 20 minutesfor $8-12. The diagnostic test can be completed within a patient appointment, leading to patient retention, patient diagnosis and immediate clinical action, as well as reduced costs for patients. The technology improves patient care by lowering the cost of laboratory diagnostic testing, supporting immediate clinical action, giving patients the rights to their results, and better preparing hospitals to respond to epidemics or clinic wide issues. The cost of the device falls belowthat for laboratory testing reimbursement today, which makes Group K’s platform more accessible to low resource clinics andpatients. The firm’s modular, microfluidic device, and mobile app with computer vision and AI revolutionize diagnostic testing by providing quantified results within minutes. This allows physicians to take immediate clinical action. This technological platform will support over 60 tests in the future with liverfunction, comprehensive metabolic panels, and complete blood counts as its initialtests. The fast response time of the technology provides results within a single appointment, allowing immediate clinical action to be taken, so that time sensitive and communicable cases are better treated as well ascontrolled. The distinct patient portal gives patients access to their result records, so all abnormal results are immediately reported, as well as overseen and given by a provider in the moment. Improving hospital preparedness for epidemics allows patient experience to improve, protecting patients against infectious diseasesor outbreaks. Another intriguing feature of the product is that it is easy to use and does not require additional training. It also doesn’t require refrigeration, and can be completed in office. This gives patients’ direct access to their results,eliminating any miscommunications that might occur in the case of 36% of abnormal results that currently go unreported. All these elements have led to seamless integration of Group K Diagnostics’ product in to the physician, and nurseworkflow. Instigating a Groundbreaking Change inHealthcare The numerous advantages of the product will ease payer demands, and allow the device to be used by physicians in specialty or primary clinics, without access to on-site labs, and needing urgent & frequent results. In addition to increasing accessibility to laboratory testing to low resource regions and patients, Group K’s product will improve time to diagnosis for all users. The need for immediate results andclinical action is crucial for improving treatment and preventing acute cases from becomingchronic. Another key feature of its software is the provider and patient portals. It will allow patients to receive and keep records of their results ensures that abnormal results are communicated and also transferred easilywhen a patient transfers providers. Group K Diagnostics’ platform prevents this miscommunication, and helps protect patients and providers. Another revolutionary application of the company’s software component is epidemic tracking using anonymized patientdata. The medical diagnostics industry continues to change rapidly and with its revolutionary application ofpoint- of-care diagnostics, Group K Diagnostics believe that it will continue to stay ahead of the trends by continuously making advancements within itstechnologies.

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20. BioSerenity: Technology at the Service ofHealthcare T The company first started providing Smart Healthcare Solutions with the focus on Epilepsy and has since expanded to Cardiology, Sleep disorders monitoring, and Urology. BioSerenity’s solutions have helped diagnose over twelvethousandpatients and it has recently raised 20 million dollars to support its growth. It tackles these challenges with the help of a rich ecosystem of partners. The company has collaborated with patient groups, academic centers, hospitals, and industry to come up with futuristic medicaldevices. Spearheading BioSerenity Bioserenity was instituted by Pierre Frouin, who is currently the CEO of the company. He holds a Master’s degree, in IT Engineering and a MBA from INSEAD, which he leverages to lead BioSerenity towards becoming one of the fastest growing medical devices company. Pierre has workedin the medical industry throughout Asia, Europe and North America, for almost his entire career. Pierre’s experiencein the pharmaceutical industry and the medical diagnostics industry has helped him understand that point of care diagnostics was going to be critical for the development of personalizedmedicine. Distinctive Products andSolutions that BioSerenityOffer The Neuronaute is the first solution developed for the diagnosis ofepilepsy based on the use of a smart textile,a he rise in the globalpopulation has triggered an increasein healthcare costs and anumber of unmet medical needs;technology offers solutions on a number of levels, reducing time, and space limitations. One such company that aids this problem by providing wearable medical device solutions is BioSerenity. Established in January 2014, the company is located within the Brain and Spine Institute, at the heart of the largest university hospital in France: la Pitié-Salpêtrière in Paris, with offices across France, China and the United-States. The company is internationalizing and expanding, with the workforce of more than hundred employees. It offers solutions formany applications in diagnosis, monitoring, and clinicaltrials. BioSerenity is a fast growing company which combines high techengineering, medical development, and Artificial Intelligence to solve four keyproblems by: PierreFrouin Founder &CEO “ We combinehigh-tech engineering, medical development, and analytics, to deliver full stack precision medicinesolutions Allowing long term recordings without increasing patient’sburden, while significantly reducing hospitalizationcosts. Reduce diagnosis errors thatare due to lack of data or misinterpretationerrors. Help patients to receive the appropriate treatment as fast as possible. Reduce patient cohorts neededfor clinical trial by providing more accuratedata. Ÿ Ÿ “ Ÿ Ÿ 18 / September 2018/

21. mobile application, and a cloud platform. The system is designed to make it possible to record physiological parameterscontinuously, including electroencephalography (EEG), and in an outpatientsetting. The goal is to give neurologists a tool to get to the diagnosis of epilepsy faster by recording patients in their home environment or in any hospital bed on the long term basis. The signals are then parsed by an A.I. assistant to help identify digital biomarkers or anomalies. Its A.I., called Serena, learns from the interpretation of Neurologists (machine learning) how to identify critical elements in theEEG that are linked to a pathology. For each recording, the A.I. analyzes thesignals, and helps neurologists focus on important periods of the EEG signals. The aim is primarily to save the physician’s time by not having to review lengthy periods of rawsignal. The company is now working on Cardiology, Urology, Sleep Disorders, and Pregnancy Monitoring. It has developed a Cloud platform thatallows it to deploy Medical Device and Mobile Apps powered with A.I. across the globe. The company works closely with doctors and researchers;this improvements. ŸArtificial Intelligence is assisting physician in their dailypractice. IoT is already helping millions of devices being better maintained,while Artificial Intelligence is still in its infancy. Future Perspective of BioSerenity The medical device industry was historically separated and often in the shadow of the pharmaceuticalindustry. Now that the Medical device industry is in the spot light, the future will generate more cooperation betweenthe two industries. BioSerenity’s next product launch is going to be in Sleep Disorders with an ambulatory polysomnography assessmentsolution. The Somnonaute is a medical device project aiming to allow a full polysomnography exam in a medical sleep analysis setting. In order toallow a full exam to be recorded, aconnected cap, shirt, and pants arerequired. Recorded measurements include electroencephalogram, electrocardiogram,electromyograms, pulse oximetry, movement, positioning, andbreathing. allows it to focus on what is most needed, instead of what is mosttrendy; to bring to the medical community the best tools possible that help patients. BioSerenity believes that thisapproach leads to faster adoption, and a leaner iteration process. It has also setup a strong regulatory team and culture; an expertise that is often missing in tech startups. Awards and AccoladesBioSerenity has Received With over twelve national and international awards, BioSerenity has received the support of doctors and patients from all around the world.The company is the recipient of the International Innovation Awards, the World Wide Innovation Challenge, Innovact Award, Connectitude Program, and manymore. Technology Trends in theMedical Device Industry Currently there are two major technological revolutions undergoing that have the potential to change the landscape of Medical Deviceindustry thatinclude: ŸIoT (Internet of Things) is allowing for remote monitoring of devices and much shorter cyclesof Profile-1 / September 2018 /19

22. Misceo GrandTechnology: Ushering towards the NextGeneration Telemedicine Technology Tessential body vitalsand here is a growing demand fora healthcare delivery with the help ofits medical device solution and advance cloud analyticsexpertise. About the Leading Light andHis Sight The company was incepted in 2013 by its visionary Founder and dynamic CEO, Mahesh Galgalikar. He holdsa Master’s degree in Electrical and Electronics Engineering from Rochester Institute of Technology, NY and has more than eight years of vital experience in medical technology development. He is the pillar of strength for Misceo and the principal inventor behind its flagshiptechnology. According to the CEO, today,everyone wants to reap quick benefits without understanding the harsh reality thatthis industry is one of the slowest moving sectors regarding product market adoption and especially in regulatory requirements. “Medical community is very rigid when it comes to adoption of new technologies. Due to rigorous standards laid down by FDA, it’s always a lengthy process to get the product ready for market,” asserts Mahesh. “Our focus is very straightforward and clear, build a product which is centered on the end users need and deliver the best quality possible in the least amount oftime.” Significant Facets of its Product Company’s flagship product is a portable one that provides accessible and insightful details related to aheart system that can monitorall activities of the patientusually monitored in ICU and helpinCardiac events prevention, diagnosis, post- operative care and ongoing management of patients throughnon- invasive monitoring. Silicon Valley- based Misceo Grand Technology is a pioneer that provides cutting-edgereal- time cardiac tracking and analysis for Hospital and clinics for both in-patient monitoring and Ambulatoryout-patient monitoring using a single medical deviceplatform. Misceo helps Hospitals to extend their services beyond their premises. It provides a connected healthcare solution to decentralize existing healthcare infrastructure and coordinate patient care services between clinics at remote locationsand hospitals. Misceo/The company first came into existence as a software analytics company for the diagnosis of congenital heart defects usingacoustic analysis of heart but soon jumped into Healthcare IoT industry and started building its H/W product line for a tele-ICU market. Misceo is workingto close the gap between inpatient and outpatient monitoring by developing a seamless medical device platform that could scale from hospitals to homes. The company intends to disrupt the home healthcare market andoptimize MaheshGalgalikar Founder &CEO “ We provide connected healthcare solution to decentralize existing healthcare infrastructure “ 20 / September 2018/

23. ailment in a technologicallysuperior manner that too at low cost and in simple & accurate terms. Apartfrom this, their product is unique in much sense. Itoffers: • Continuous Monitoring: Misceo Access is the only continuouslong- term multi-sensor ambulatory monitor to be in themarket • EHR Integration: MisceoUnity infrastructure will seamlessly integrate with hospitals EHR systems to deliver hassle free solution • Error-proof: The ergonomicdesign of Misceo Access eliminates common errors due to ECG patch misplacement • Reusable: Misceo Access canbe used time and again (Electrode patches are the only disposable element) • Efficient Procedures: Monitoring device moves with the user, so transitions from one procedure or location to the next are seamlessin Hospitals • Multi-parametric Status Monitoring: Provides Continuous6 Lead ECG, PPG, O2 Sat, Body Temperature &Activity • Virtual Oversight: AI leadoversight for continuous patient monitoring reduces the burden onphysicians, cardiologists, and technicians in Hospital and thus assists inanalyzing patient data and alertgeneration The Scenario of MedicalDevice Industry Hospital readmission is a primary concern these days. If hospitals don’t reduce preventable 30-day readmissions, they stand to lose a substantial amount of revenue as per Hospital readmission reduction program administered by CMS in 2012. An effectivetelemedicineservice is the solution to thisproblem. Although, there are many MCT devices available, but none assist the hospitals in a way that can reduce financial losses. Thus there is a dire need for a system that would scale effectively from inpatient monitoring scenarios to outpatient monitoring and provide more clinical grade information to help cardiologist come up with a diagnostic solution rather than just alert creation. High cumulative consumer costs (due to non-reusability), dependence on the device company for raw data retrieval, the company technician’s accurate collection and reporting of raw data, and generation of a summary reportare some of the numerous disadvantages which current medical devicespossess. To alter this scenario, Misceo developed its wireless solutions that continuously monitor multiple body vitals and therefore providearrhythmia burden, but can also wirelessly send critical arrhythmic events in real time for timely diagnosis andtreatment. Future Outlook There was a time when the medical device industry was more focused on curative measures and understanding the progression of a disease. Today, it is moving towards preventive healthcare as more and more emphasis is given on disease prevention. Soon, technology like AI will assistscientists to unlock many mysteries towards the cause of diseaseprevention. “We feel with the technology in development at Misceo, we would be able to have a better understanding of human cardiac conditioning and progression of various symptoms in various cardiac and COPD conditions which would help us preventsignificant medical conditions,” concludes the CEO. “Company intends to scale the solution for simply hospital scenario to a full-fledged home healthcare solution for chronic patient management by 2019.” / September 2018 /21

24. Telemedicine The Fastest Growing Segment ofEmerging Services in HealthcareIndustry Awith masses of talentedpeople, is anation of underdeveloped physical lthough initially considered by some of the critics as ‘far away in future’ and‘still in experimental stages’, telemedicine is a living and thriving reality today.India, infrastructure. Telemedicine provides a potential opportunity to leapfrog steepchallenges faced by such existing inadequacies in physical infrastructure for healthcareservices. Telemedicine is a system where doctors and patients can share information in real timefrom faraway locations one computer system to another. They can have patient’s check-up through medical devices and can also capture the readings for diagnosis. Telemedicine is widely applicable in patient care, public health, and administration, hospitals andeducation. System and Network Set-up Telemedicine technology comprises software and peripheral components such as web camera and dish antenna to receive the signals or a broadband connection. There is an interface created between hardware, software and communication channels with satellitesor internet to ultimately bridge two people in differentlocations. Utilities forPatients Patients and doctors can interact via the webcam-based interface, and communicate for diagnosis and treatment. When patients need to consult with their primary carephysicians, they can submit the request in the system. The physicians placed at a remote location are immediately notified and can respond by activating an audio-visual interface. Even if the concerned physician is not available the request is transferred to other doctors in the nationalnetwork. Unlike in general hospitals where they may have to wait for an appointment,telemedicine provides instant access to doctors. The service can be made available to patientswith 22 / September 2018/

25. / September 2018 /23

26. medical consultation off hours. Especially with the critical necessity of specialist doctors who may not be availablelocally. They can help monitor the rare and chronic conditions of thepatient. Telehealth for CommonMan The terms telemedicine and telehealth are many times used as synonyms. But some of the experts are of opinion that telemedicine is the physician focused term and tele-health is used to refer all health professionals. Hospitals or healthcare organizations involved in implementing telehealth or telemedicine will be able to distinguish between the two astechnology becomes advanced and popular for the commonman. Benefits ofTelemedicine The biggest benefit is the availability of expert specialist to all patients in remote locations if the need arises. Patientscan avoid the cost of transportation or avoid wasting time in traffic with video consultations from the comforts of his home. Individuals engaged by their work can also schedule a consultation during a break or even after work hours and will not miss any day of work for the sake of minor health problems. As specialists are rare and short in supply, patients like children or elderly people can use telemedicine solutions without the struggle for their specific healthconcerns. Recent Trends for Adopting NewTechnology Patient self-monitoring was a big trend recently for using the medical records and health-related data with moderndevices and smartphones available. For example, small digital devices are available today which can track patient ECG’s andsend the report to doctors, providing an invaluable tool for healthcare professionals to monitor cardiovascularactivity. Hospitals and insurance companies are using emerging cloud technology to store electronic medical records. These are accessible to patients also who can see their test results and medical reports online. One of the main reasons why it has enjoyed success is because of increased customer satisfaction numbers. Telemedicine and related mobile applicationsare much more efficient in data collection and making research much more reliable with the well-documenteddatabase. Implementing a TelemedicineProject Telemedicine program should be that helps in identifying the specific needs of a community. These needs can be susceptibility to certain ailments or nutritional deficiencies as a result of cultural or social bias. Geographical variationsalso communities may have a large number of citizens who need diabetes or nutrition relatedcounseling. Training of Staff for Patients’Acceptance Well-trained professionals, related to both technical aspects and health care emergencies, must be available with adequate knowledge, experience, and job-related skills. The team implementing telemedicine project should ensure that thestandard procedure is followed while using theequipment. Patient’s acceptance is an important parameter where patients can feel comfortable using the facilities and that can save time for other social activities. In addition to connecting patients with a primary care physician, telemedicine canfacilitate access to specialists and super-specialists and also to the team of experts in particular kind of disease. Telemedicine saves time and money by avoiding travel for both doctors and patients. It also allows patients to remain in their communities, which means they will fill prescriptions, purchase healthcare accessoriesetc. Emerging Frontiers inTelemedicine Telemedicine technology is emerging as one of the fastest growing segments in the healthcare industry. Many organizations are taking it as a preferred destination to park their money and investment is increasing steadily. The global telemedicine market has shown the growth by around 18% CAGR. Readily accessible care, reduced healthcare costs, productive workforce, and enhanced patient experience are some of the main reasons why telemedicine is becoming popular. Ashifting economic background, developments within the healthcare industry, responsive and conducive legislative environmenthave already created fertile ground for telemedicine to grow. Smartphones and internet-capable mobile devices may be the driving factor behind the success of telemedicine. The gadgets and the growing popularity of artificial intelligence and the internet of things are taking the possibilities to new heights. Out of healthcare delivery methods intended to play a greater role in healthcare, telemedicine is the most promisingone. 24 / September 2018/

28. Motiv: Providing Subtle, Sleek & Sophisticated WearableDevices F orm factor, durability,stylish and businessman. As a mechanical engineer, he worked on various projects and quite a few IT companies; it was during that time that he realized that his work-obsessed and sleep- deprived lifestyle was less than ideal. He wanted to get a device that could allow him to track his sleep and health better, he tried what was on the market and those options didn't work for him, and he was inspired to make a seamless experience for people in a ring form factor. “Innovation in wearables doesn’t happen overnight. Change is typically the result of a lotof research and development followed by difficult engineeringchallenges. Building an amazing and capableteam is one of the best ways to get there,” says vonBadinski. Progressive, Passionate, & Experienced Leader ofMotiv Tejash Unadkat is the CEO of Motiv; he joined the company in 2017. He oversees all elements of the business including sales expansion, product development, people management, and company growth. Under hisleadership, Motiv has expanded its operating system support (now on both Android and iOS), retail distribution channels (including Amazon and Best Buy), platform compatibility (Alexa, Apple Health and Google Fit), and a slew of health partnerships (including Pear Sports, Plus 3 and Lindora.)Tejash design and the integrationof leading-edge technologyfor precise data collection are some ofthe factors that define a superiorwearable product. One company that considers these factors with precision and craft products that people want to wear is MotivInc. Motiv Inc. is a breakthrough wearable technology company designing products that fit seamlessly into people’s lives. Motiv Ring was announced in January 2017 at the Consumer Electronics Show and officially began shipping inSeptember. Its debut garnered a terrific response and glowing reviews from a multitude of prominent media outlets. It has a user-centric design which is both comfortable and state-of the-art.Motiv Ring is not currently a medical device; however, the company considers this form a stepping stone to evolve as a true medical device company in the future. An Innovative, Accomplished,& Design DrivenCompany Motiv began when Co-founder and CTO Curt von Badinski had a light- bulb moment that convinced him touse his tech expertise for a small and lightweight fitness tracker that could make people’s lives better. Curt is a serial tinkerer, inventor,entrepreneur TejashUnadkat CEO Curt vonBadinski Co-founder &CTO “ We provide subtle, sleek, and sophisticated wearable devices that are comfortable and people want to wear “ 26 / September 2018/

29. believes in building products that are useful to the people twenty-four hours of the day, seven days a week —across the health, wellness, access, security, and paymentsspectrum. Idiosyncratic Features of MotivRing Motiv Ring is the first medical device that blends in; this smart ring tracks heart rate, activity, and sleep. Motiv Ring is waterproof up to 165 feet. At less than 0.1 inches thick, it is about as thin as a nickel and weighs less than a penny. The titanium-shelled ring holds a charge for three days, and connectsto the Motiv App available on both iOS and Android. It is about one tenth the size of its competitors, which makes it a people’schoice. While the wearable space is a crowded one, Motiv’s two biggest differentiators are the form factor and sensor data. The company has spent a substantial amount of time and effort on the development of its form factor while working their way down to the technology. Its considerably small size makes Motiv Ring an engineering marvel. Motiv has developed aproduct with components that are smallerthan a grain of sand. Motiv Ring is entirely custom made, right from the sensors, circuit boards, and battery. Motiv has taken the technology of a wrist-worn device and miniaturized it into a 2.4mm-thick ring. Finding the components — batteries, sensors, titanium shells that could accommodate its small size — was a challenge. Despite the challenges the form factor posed, it is hugelyresonant with Motiv's customers whoappreciate that the minimal, not clunky look, and that their wrists are free once again for watches, bracelets, or nothing atall. The Benefits of aFinger-Worn Device As far as sensor data is concerned, Motiv Ring has advantages over wrist- based devices. Tattoos or even armhair can affect the quality of heart rate data while wearing a wristband. These problems are far less common on the finger and palms, which also helps with heart rate data collection. The company’s ring fitting process, with seven unique sizes, allows users to get the right fit. A proper fit is imperative for collecting the bestdata. Additionally, Motiv Ring uses a benchmark of active minutes, rather than steps, to measure heart health. These active minutes are tracked any time one is active for more than 10 minutes. Thus, “cheater” steps - those back and forth to the fridge or to the couch - are not rewarded as activity. This benchmark keeps its usershonest and their hearts healthy. Apart from this the ring is always with the user - durable, stylish, comfortable, and lightweight; it’s motivation wrapped around one’s finger. Motiv Inc.’s FuturePerspective Motiv is continuing to expand its functionalities, partnerships, distributions, and integrations on a monthly basis. This continued momentum is important for the company’s growth. Motiv just announced its Google Fit integration in July, and will be announcing a seriesof healthcare partnerships with leading health tech companies in the coming months. Later this fall, the company will be introducing another version of its beloved ring and will enter into the biometricsspace. / September 2018 /27

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32. Organs-On-Chips A Potential Drug-testing AlternativeApproach Namounts of funds andtime on theresearchand ew drugs, medications and therapies arediscovered every day. Pharmaceutical companies spendenormous development of novel drug targets strategies. In spite of allthe effort not all the medications and therapies make it to themarket. There is a dire need of a solution to accelerate drugresearch. For quite some time now cell cultures in petri dishes have been used to test the efficacy of new therapy, but this method does not give us a full proof knowledge of the working of the therapy.Cell cultures in-vitro do not react to drugs in a way similar to how they would retort inside the human body. Moreover, animal testing is a time-consuming, expensive, and is not satisfactory enough to prove the efficiency of a treatment onhumans. Numerous drugs and therapies pass the animal tests, but end up being proved detrimental to humans; because traditional animal models often do not precisely mimic human pathophysiology. More than $2 billion are spent on a single compound being clinically tested. Meanwhile, countless animal lives are also lost. For these reasons, there is an exigent need for alternative waysto fast-track the development of new drugs and improve personalizedmedicine. To address this pressing issue scientist have come up with a new technology “organs on chip.” These are Cell cultures, often in 3D, that use microfluidics to mimic the way a tissue or part ofan 30 / September 2018/

33. organ work. From breathing lungs to beating hearts, organs-on-chips are some of fieriest novel tools forhuman biology research. Although these devices may bear closer semblance to computer constituents than human body parts, scientists have now produced working models for a whole assortment of organs, including the lung, the liver, and eventhe female reproductivesystem. Scientists hope to use these devices to modeldisease and ease drug development. Organ on chipresearch has already permitted us to create numerous microfluidic chips that can partly mimic organ function. Multi-organs on chip might also allow us to observe the side effects of drugs ondifferent organs, and not keep the study restricted to those organs that the treatment targets. The goal is to be able to link a maximum ofparts in order to, allow one and all to have access to customized treatments by using their one’s own cells to test them, which is termed as personalizedmedicine. Functioning ofOrgan-on-Chip It is improved computer microchip manufacturing method to engineer microfluidic culture devices that reiterate the microarchitecture and functions of living human organs. These micro devices, propose a prospective substitute to traditionalanimal testing. Each organ chip constitutes a clear flexible polymer approximately the size of a computer memory stick that encloses hollow microfluidic channels lined by living human organ specific cells. These cells are interfaced with a human endothelial cellslined on an artificial vasculature; mechanical forces can be applied to this set up to mimic the physical microenvironment of living organs, which includes the peristalsis-like deformations in the intestine and breathing motions inlung. They are fundamentally three-dimensional, living cross-sections of chief functional components of complete living organs. The translucent nature of the device, allows scientists to view the inner working of the human cells without invading the living body. With their capability to host and combine the diverse cells and tissues, organ chips present an idyllic microenvironment to studymolecular and cellular activities that bring about human organ function and imitate human specific disease conditions, as well as pinpoint new therapeutic targets in vitro. This device, intended to mimic whole-body physiology, controls fluid flow and cell viability while simultaneously permitting real- time observation of the cultured tissues and facilitates analysis ofthe intricate connected biochemical and physiological responses across ten different organs. This complete “Human Body-on-Chips” method can be used to predict human pharmacokinetic and pharmacodynamics reactions of drugs invitro. / September 2018 /31

34. Heart on Chip Speaking of serious health problems, heart disease certainly tops the list. The number of deaths due to heart failure is escalating day by day. Hearts-on-chips were developed, specifically because of the substantial differences between animal and human heart cells. Using this technology scientists aim to study heart diseases and cardio-toxicity of chemical treatments. In comparison with regular cell culture, microfluidic chips allow collecting more relevant data. The chip comprises of several wells, each with separate tissues and integrated sensors, permitting expertsto study various engineered cardiac tissues at once. The chips have the potential to become the best tool to study new treatments against heartdisease. Lungs onChips Today the primary goal of the healthcare space is the development of novel solutions to treat pulmonarydiseases. Studies have shown that lung diseases are the fifth largest cause of death, and are predicted to be the third by 2020,all around the world. To address this issue it is important to develop strategies and drugs that can be made available to the public quickly. In this circumstance, using lungs on chips to facilitate the development of new treatments has shown a potential wayahead. The device mimics a living, breathing human lung on a microchip. The device, about the size of a toffee, acts much like a lung in a human body. It is made using human lung cells and blood vessel cells. At present scientist are still unable to mimic the exact entire lung on a microfluidicchip. Nonetheless, researchers have succeeded to replicate the function of an alveolo-capillary membrane that is the tiniest functional unit in the lung. This organ is the most vital part when it comes to testing of new medicines, as it constitutes the vital physical barrier between the body and the exterior world. This device has the potential to become a valuable tool for testing, absorption of aerosolized therapeutics, effects of environmental toxins, and the safety and efficacy of newdrugs. 32 / September 2018/

35. Organs-On-Chips Gut on Chip Another organ here is the gut on a chip. The gut is acrucial organ when it comes to absorption of medicine, and this breakthrough technology would help us comprehend these issues better; and fast forward research. Scientists have developed a two-layer gut on chip system, similar to the lung on chip discussed above. This technology, much like the lung on chip, has proved to be very important, since it has permitted to re-create the mechanical tension, simulating peristaltic movement. During a particular study using this technology, the researcher used stem cells froma patient, who was suffering from digestive disorders, and developed with a gut on chip tool. Using this, experts were able to study the responses of the certain types of food and new treatments. This illustration comes to show what personalized medicine could look like, using organs on chips. Brain on Chip Brain on chip research has helped to replicate a small partof the brain, ‘the blood-brain barrier’, on chip. This barrier has a crucial function: of protecting the brain from all the pathogens in the blood and only lets through the nutrients the brain needs. On the other hand, this barrier can be problematic for some drug treatments, because it bars selected active sites from accessing the brain such as the medication against Parkinson’s disease. These microfluidic chips permit experts to test the flow of a physiological fluid on the epithelium; this mimics the blood flow and allowsthe brain cells proper differentiation and maturation. In spite of the fact that research in the field of blood-brain barrier microfluidic chips is only starting out, several models alreadyexist. / September 2018 /33

36. Organs-On-Chips Multi-Organs on Chips In the near future if developing organs on chips proved useful for testing certain treatments, in order to absolutely replace animal testing or to simplify personalized medicine, it is essential to link these organs together. While developing a new treatment strategy or drug it is vital to check the effect of these on the entire body as a whole. Thisis where multi-organ on chips can help out. Most multi-organs methods have also permitted scientists to studyabsorption and metabolism. Multi-organs on chips have allowed experts to carryout tests on previously existing medicine, meanwhile also allowing the progress of anti-cancerresearch. Promising Applications of theTechnology Organs on chips can prove to be cheap and widely reproducible could be decisive. They could permit testing at a very low cost, minus years of waiting periods. They will also cut down on the present ethical concerns, which come with animal testing. This technology will provide increased access to personalized medicine. Organ on chips will help fight the battle against cancer. Creating tumors on chips, would allow us to directly test the treatments on tumors. It willalso allow us to determine the side effects of certain treatments in advance. However, many challenges need to beaddressed in order to completely replace animal testing in the development of newmedicine. 34 / September 2018/

38. TrexoRobotics: Delivering Futuristic & Innovative Pediatric Wearable RoboticDevices Othedifferentiallyabled;but ver the years,various looking to redefine mobilitysolutions for people of all ages and abilities,by building affordable and effective products that empower individuals to move and live a healthylife. Fundamentally, the company isdriven by the belief that people should have access to empoweringtechnologies. The Accomplished &Innovative Leaders ofTrexo Trexo Robotics was founded in 2016, by Manmeet Maggu (CEO) and Rahul Udasi (CTO) as partners. They began experimenting with various robotics designs until the revolutionary Trexo device came to life. Today, the Trexo Plus is being prototyped and is set to be piloted in an upcoming trial with the Cincinnati Children's Hospital. Praneit’s story has shapedthe company’s values and mission to strongly focus on the children’s experience and to learn from its end users, including children, parents, and physiotherapists in order to build enjoyable and affordableproducts. Feather in the Cap of Trexo Together, the Trexo team has experience bringing over 200 products to market, taking these products from ideas to mass production. These and the founder’s experiences have rooted Trexo’s culture in continuous innovation. Manmeetstronglybelieves that robotics has the potential forthe solutions have come up toaid few were focused specificallyfor children with disabilities. Today, children with mobility impairments spend a lot of time sitting, which has been shown to lead to negative health outcomes in the long-term. Withoutthe ability to walk, many children have a hard time getting adequate exercise and stayingactive. The story of Trexo Robotics began in 2011 when its CEO Manmeet learned that his nephew Praneit had cerebral palsy and would not be able to walk. With a desire to help his nephew, Manmeet and his friend Rahul, CTO, decided to take the matters into their own hands. They both studied robotics at the University of Waterloo, so building a robot to help Praneit madea lot of sense. Thus Trexo Robotics was born in2016. Trexo Robotics designs and builds pediatric wearable robotic devices to help children with mobility impairments experience walking. Its’ product, Trexo Plus, is the only fully mobile robotic gait training platform that is commercially available for children. Trexo’s vision is to makethis technology available for home use so that every child is able to walk regularly. Through this vision, theyare ManmeetMaggu CEO & Co-founder Rahul Udasi CTO &Co-Founder “ We want to reach the point when every family that has a child with a disability, will have access to and use the Trexo device, giving children more options and independence “ 36 / September 2018/

39. betterment of society. Rahul, on the other hand, is an enthusiast of innovative robotics and is driven byhis curiosity. Technologically, the company is at the frontier of robotic design. The Trexo team frequently tests its prototypes with various children who could benefit from this technology andlearns from their experiences. Recently, following its participation in the Canadian Technology Accelerator Boston program, Trexo Robotics, won a MIT Enterprise Forum Startup Spotlight Award for theirlife-changing innovation. Trexo Plus: Strengtheningthe DifferentiallyAbled Trexo Plus is the only fully mobile robotic device designed specificallyfor children to walk independently. Its unique design allows it to convert a passive walker into a fully powered robotic device that can be used anywhere. While starting as a physical therapy device, Trexo’s goal is tomake this device accessible to children and their families at home so that they can experience walking outside of aclinic. The designs are made with a child’s comfort and needs in mind, and children with various conditions are frequently invited to Trexo’s office to try out the device and provide valuable feedback. Ultimately, Trexo’s goal isto create a device that physical therapists trust, parents can afford and children love. There are currently no such devices available that can be used at home by children. This device may be used by children with conditions including cerebral palsy, muscular dystrophy, traumatic brain injury, spina bifida, spinal cord injury and other conditions which lead to mobility impairments. They strongly believe that leveraging novel technologies can have a strong impact on the care of people with disabilities, as well as healthcare overall. For instance, 3D-printing has also allowed Trexo to test parts and identify potential sources of issues quickly, ensuring that when its device hits the market, it is of high quality. This type of rapid testing has alsobeen essential in keeping the company sustainable and moving quickly. In the future, Trexo is consideringintegrating machine learning to improve the gait training of each child as progress is made, ensuring that the childcontinues to benefit from the use of thedevice. Present & Future of Trexo& MedicalDevices The sad truth is that there isn’t much innovation happening in the accessibility and mobility space. This market is still frequently overlooked because there are significant barriers to entry. Trexo hopes that by showing people that with the usage of advanced technologies like robotics, one canhelp people in improving their lives and create a profitablebusiness. Positive changes are happening, and care providers are appreciating the value of innovative technologies to improve the quality-of-life of their patients. At the end of July 2018,Trexo will be placing its first unit for clinical testing at the Cincinnati Children’s Hospital. Additionally, it plans on deploying four more units before the end of 2018 for furtherevaluation. Trexo is currently preparing forFDA submission aswell. / September 2018 /37

40. AI isStarting toChange Radiology, forReal T(RadiologySocietyin NorthAmerica)andISMRM he AI transformation is remarkable for itsspeed. For example in conference such asRSNA (International Society of Magnetic Resonance inMedicine), AI applications was still a niche area before 2016, but isthe top-1 hottest topic right now. We have passed beyond the point that people doubted the applicability and potentials of AI in radiology. Machine Learning and Deep Learning algorithms have demonstrated good performance that can supplement and verify the imaging tasks forradiologists. Although still in early stage, variable AI algorithms have already started to be test in clinical environment. This year 2018 is also a landmark year for AI in radiology, since several AI+radiology products have received FDA’s nodding that they can practice in clinics for segmenting heart from MRI, make classification from CT, evaluatelung nodules,etc. Beyond Classification - AI Improves EntireRadiology Workflow Particularly, when talking about AI for radiology, most people think of an AI algorithm that can eventually “replace” radiologists and conduct diagnosis. Whenpeople talk about the possibility of “replacing” radiologist, it is important to recognize the complexity ofradiology. Radiologists are imaging experts with more than 10+ years of medical training, who render diagnosis and clinical decision suggestion from interpreting medical images and correlating their findings from images with other examsand Dr. EnhaoGong SubtleMedical About theauthor: Dr.EnhaoGongisthefounderofSubtle Medical. Dr. Gong graduated with a Ph.D. in Electrical Engineering from Stanford University in 2018, with research focus on applying Deep Learning to improve medical imaging reconstruction, analysis, and quantification. He has been awarded Forbes China 30-under-30 in 2018, and serves in the committee of Machine Learning Workshop of ISMRM. Subtle Medical Inc., is an AI+Radiology startup founded by Dr. Enhao Gong and Professor Greg Zaharchuk from Stanford University, it is the Winner of 2018 NVIDIA Inception Award and Minnie Semi-finalist of Best RadiologyVendor. 38 / September 2018/

41. TransformingRadiology tests. Currently, most AI algorithms are often designed for simplified ImageNet-ish image classification tasks, to separate images from different categories such as with or without abnormality. It is clear that there are still hugegaps between predicting a classification label, which is well studied and achieved by AI algorithms, and rendering final diagnosis, which is much more complicated and requires both images and non-imageinformation. Beyond image classification, however, AI actually has great potentials to improve entire imaging/radiology workflow. AI algorithms and products can supplement existing radiology solutions, with more efficient and accurate imaging acquisition, reconstruction, analysis, detection, diagnosis, and prognosis, which goes way beyondpredicting labels of normal and abnormaltissues. Several research works, including the works we have done at Stanford; recently demonstrate that Deep Learningcan replace conventional iterative algorithms for more accurate medical imaging reconstruction from 10x faster MRI scan or even 200x lower-dose PET scans. In addition, a lot clinical research works in neuroradiology; showed AI algorithms can not only categorize current disease, but also predict how the disease will progress in the future.From faster exams to accurate prognosis prediction, the entire radiology workflow can be improved usingAI. DifferentfromotherAI+radiologycompaniesandstartupsfocusonautomatingradiologydiagnosisusingAI,weat Subtle Medical chose a different route to integrate AI into clinical radiology. We provide hospitals and imaging centers software infrastructure for AI-empowered imaging workflow enabling at least 4x faster and safer MRI and PET exams. We believe these AI tools will help hospitals and imaging centers to improve their productivity,quality of the service and patientsatisfaction. No Workflow Disruption from Disruptive AITechnology It is no doubt that AI is a disruptive technology that will reform the radiology practice and workflow. However, the innovation in radiology practice, as well as in healthcare in general, should never disrupt clinicians’ operation.There is a saying that if the change of workflow requires radiologists to move from their chairs, it is not going to works. AI is supposed to free clinicians from repetitive tasks, not to add more tasks to them. Therefore it is fundamental for an AI product to seamlessly integrate into the entire workflow. For example, at Subtle Medical, all the products are designed in a way to (semi-) automatically function between scanners and PACS, staying almost silent and invisible to technicians andradiologists. In general, we believe the best radiology tool should simplify, accelerate, and prioritize tasks for radiologists,making exams more accurate, efficient and personalized, and improve the productivity and satisfaction for both patients and clinicians. AI products have potentials to achieve all of theserequirements. Super-human Capability ofAI Several research works show state-of-the-art AI algorithms, such as Deep Learning, have great potentials in tasks human professionals are not good at as well. For example, in identifying diagnosis disease subtypes, similar to fine- grained image classification of identifying two similar dog breeds in ImageNet challenge, AI algorithms can do better than human and resolve inter-reader variability. In addition, for all the repetitive and quantitative measurements in radiology, such as contouring, segmentations, measuring brain thickness, and recording tumor size changes, AI algorithm can not only free clinician from these time-consuming mundane tasks but also get more accurate results. In addition, quantitative biomarkers and quantitative parameter mapping is a new trend in medical imaging as it offers better objective criteria for clinical decision, where Deep Learning is shown to improve forMRI. Last but not least, new algorithms lead ways to correlate radiology with large scale genetic datasets, which istoo complicated that human can never be good at but AI. All of these new advances from AI can contribute to personalized and precision medicine in futureradiology. / September 2018 /39

42. Still a Long Way toGo Although AI in radiology has achieved a lot progresses, there are still a long way to go until it is routinely usedin clinics. In 2016, Dr. Geoffrey Hilton mentioned “it is quite obvious that we should stop trainingradiologists”. Later, several AI papers published on achieving “expert-level performance” in diagnosis add-up the concernsthat radiologists should be worried about losing jobs. However nowadays we know there are definitely some hypes in “replacing” radiologists. As the developers of radiology AI, we also understand and appreciate more that radiologists are doing much more than image categorizing. Most AI/Computer-Assisted-Diagnosis products are still in their early stage for a closed-set of a few diseasecategories. AI, for a foreseeable future, will not be generalized. No human is better than a small calculator for accurate arithmetic, but that is all that the calculator can do. Given the long-tail effects and the lack of datasets for rare disease, it is unlikely AI can do everything for radiologists. But, as put by Dr. Langlotz from Stanford, “radiologists who use AI will replace radiologists who don’t.” AI in radiology, probably similar to AI in other popular areas such as manufacturing and autonomous driving, will keep improve its capability to change theentire industry. As quoted in a recent Forbes article on robotics: AI will replace tasks, notjobs. 40 / September 2018/

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44. Zenflow: Driving the Future of BPHRelief with InnovativeSolutions P roblem-solving has longbeen Conquering Challenges sincethe VeryStart After establishing Zenflow in 2014,the main challenges were to build a device that could solve the identified need, to prove that the device worked, and to secure funding for the company. The founding team of Zenflow addressed that the funding had to come first, before the other challenges. Being resourceful, they pursued all available options, including investor funding, grants, and business plancompetitions. One of the biggest early breaks for Zenflow was being funded by Y Combinator as a part of the winter 2015 batch. It turned out to be a great experience. Zenflow leveraged this program to build its first working prototype, collect chronic animal data, and raise a seed round. From there, a team was hired and Zenflow started making faster progress. It started a first-in-human study in mid-2016 and has collected some very promising data. Now, with a team of 15 full-time people, Zenflow is initiating largetrials to prepare for commerciallaunch. Innovative Products andServices Zenflow is developing the Spring System, which involves a smallNitinol implant deployed through a flexible cystoscopic system underdirect at the centerof entrepreneurship. Theright solutions bring in the right idea andthe right idea executed with the right set of skills, creates wonders. Today, the speed at which the technology hasbeen developing is ineffable; and with it there have been continuousinnovations in various sectors of countless industries. The healthcare industryisn’t aloof of this pattern. Yet the healthcare sphere, even after the digital revolution, has not seen the amount of development that it should have. There is a lot of scope to improve the health and subsequently the lives ofpeople. All it takes is the will and expertiseto do so. Zenflow is a company started out of the Stanford Bio design Fellowshipin 2014 after witnessing the distress of many men who were frustrated with their symptoms of BPH (enlarged prostate), and unhappy with the treatments available. Zenflowis NickDamiano Co-founder &CEO “ We aim to improve patient care by providing a uniquely safe and effective treatment for men with BPHsymptoms developing an office-based treatment to relieve the symptoms of BPH. It aims to develop a less invasivetherapy with long-lasting effectiveness thatcan be delivered in the doctor’s office with minimal patient discomfort. While its clinical trials are still in progress, the results so far look verypromising. “ 42 / September 2018/

45. visualization. It designed the implantto provide solution for long-term risk, while avoiding adverse effects like migration and encrustation, issues that plague prostatic stents. The designed device is uniquely made, so that it can push back the prostate while being deliverable through a small, flexible catheter in a simple procedure that is easy for any urologist to learn and perform. Zenflow is focused on the patients’ need above all; always innovating to improve safety, effectiveness, and patientexperience. Compassionate and ZealousLeaders ofZenflow Nick Damiano, Co-Founder & CEO, is seasoned with his experience as an engineer and an entrepreneur, in both medical devices and digital health industries. He founded Zenflow along with Shreya Mehta, Co-Founder & CTO. She has an experience as aR&D engineer at large medical device companies and has spent four years as a lead reviewer at FDA. Both founders spent a year in the Stanford Bio design Innovation Fellowship. The founding team’s medtech background has given them the practical know-how they needed to get their product tomarket. Adding to it, their experience from outside the industry and from the other side of the regulatory table hasbrought new perspectives to their work at Zenflow. In particular, the team takes a collaborative approach in its interactions with regulatory bodiesand other medical device companies, sometimes even competitors. With improving patient care at the core of their mission, Nick and Shreya are making their way to achieving that goal, aspartners. Staying Abreast withChanging Trends Zenflow makes it a point to stay ontop of changing conditions in the therapeutic space and market; and thrive to adapt quickly to a clinical need or changing landscape. In particular, its major strategy iskeeping the communication lines open with customers – patients, providers, and payers. Addressing the clinical needas well as possible is Zenflow’s top priority. In terms of technological changes, Zenflow has adopted 3D printing for prototyping. With a passion for success, every day matters to the team of Zenflow; and 3D printing gives them an ability tocut their iteration cycle time down to a fraction of what it would have been years ago. It has made Zenflow a faster, leaner, and more innovative company. In working towards their goal, Zenflow has not been afraid to question its assumptions and adaptif changing conditions or new information warrants doingso. Plan for an Avant-GardeFuture As far as its long-term strategy is concerned, Zenflow likes to play its cards close to the vest. Its ultimate mission is to provide the safest, most effective, most worry-free treatmentfor BPH symptoms to all the patients suffering from the disease. Zenflowhas some interesting concepts in its works, which may expand the patient population under treatment and produce even better clinical results. It also has some ideas that could allow Zenflow to branch out into other urologicareas. / September 2018 /43

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