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Improving the Medical “Root          for physicians. Recorded                    TOP WEARABLE                                                                  wearable medical devices             recorded through these devices.
        Cause Analysis”                      data from such devices is                                                                                                 are also focusing towards
                                             transferred electronically, and                MEDICAL                                                                    the development of breathing         Healthcare Wearables – the
        Traditionally, body-borne            the doctor can assess important                                                                                           sensors to monitor respiration       Regulatory Perspective
        computing devices are apt for        incidences.                                 DEVICES IN                                                                    and blood pressure (BP) sensors
        medical diagnostic purposes.                                                                                                                                   to register critical changes         The transformative potential of
        Conventional ways of checking        The device and its mobile app                   TODAY’S                                                                   in blood pressure. Some              wearable medical devices is no
        blood pressure and blood sugar       may show data on erratic                                                                                                  devices are also equipped with       longer restrained to medical
        required complex, invasive           changes in body temperatures                    MARKET                                                                    complex sensors such as the          treatments and healthcare
        procedures, the results of which     during a specific time – and this                                                    Withings Blood Pressure is           electromyogram (EMG) sensor          services as these devices are
        were not available instantly.        data can help physicians detect                                                       one of the first connected          that records muscle activity or      managing to swiftly navigate
        Popular medical wearables            the root cause of such recurring                                                       wearable medical device            the electroencephalogram (EEG)       the interlaced and intricate
        available in today’s market have     instabilities. Patients can reveal                                                   available in the market that         sensor that monitors electrical      regulatory approval framework
        replaced these procedures to         activities they engage in, or the                                                    can monitor and take three           stimulations within the user’s       of the FDA. The administrating
        an extent as end-users show          foods they consumed during                                                           measurements of the user’s           brain.                               body’s announcement of smart
        a marked affinity towards            this period, which could further                                                      blood pressure variations                                                regulation that directs more
        non-invasive procedures and          help the doctor to recommend                                                           and report the average             Wearable medical devices             oversight towards high-risk
        real-time results.                   some prohibitions. Traditional                                                        to connected devices and            that can offer such critical         technologies is a promising
                                                                                                                                           databases.
                                             measures to detect the cause                   PebbleTime, a sleep                                                        monitoring procedures                development in the advantage
        As they reduce the need for          of temperature fluxes failed                   measuring wearable                                                         effectively can put an end           of large players who want to
        physically visiting doctors for      to identify incidences that                  smartwatch with built-in                                                     to a wide range of existing          develop a universal platform for
        common diagnostic procedures,        triggered such fluctuations,               health tracking applications;                                                  medical monitoring systems           wearable medical technology.
        medical wearables will also          but real-time monitoring in               can be paired with the Android                                                  and products. In addition, the
        witness higher adoption at           wearable medical devices                  Sleep App (Sleep as Android).                                                   adoption of these medical            Wearable technology is also
        diagnostic centers, specialty        has eliminated this hindrance                                                                                             wearables will further               crossing the boundary from
        clinics, and pathology labs.         altogether.                                                                                                               supplement a physician’s ability     consumer electronics devices
        Wearables designed for                                                                                                                                         to denote the health monitoring      to regulated medical devices. A
        improving self-management                                                                                                                                      of a remotely located user.          clinically-focused evolution of
        abilities are also becoming key                                                                                                                                Connectivity functions are           healthcare wearables, however,
        diagnostic instruments                                                                                                      AliveCor Heart Monitor             preloaded in every wearable          is irking the FDA authorities
                                                                                                                                     has gained popularity                                                  who are concerned more about
                                                                                                                                    as a smartphone-based              medical device available in the      the potential problems caused
                                                                                                                                    electrocardiogram used             market.                              to consumers, rather than the
                                                                                                                                   actively by heart patients.                                              security of these wearable
                                                                                                                                  Making Remote Monitoring             Some advanced medical
                                                                                                                                        More Formative                 wearables also facilitate cloud      devices.
                                                                                           Fitness enthusiasts are                                                     connectivity. This means that
                                                                                        already privy with the Fitbit                                                  any crucial irregularities           Wearable medical devices
                                                                                        Surge, a wearable band that                                                    in the user’s health will be         associated with fitness apps,
                                                                                       keeps tabs on heart rate with               Wearable sensors for remote         informed to all concerned            diabetes management or
                                                                                        built-in optical monitor, and              healthcare monitoring               medical practitioners treating       similar medical intentions
                                                                                         also uses GPS to track the                systems are being developed         the user, and will also update       are steering clear of the FDA
                                                                                         outdoor activity of the user.             to improve the accuracy             existing electronic medical          crossroads, while the ones
                                                                                       The Fitbit Aria is also popular             of clinical assessment.             records through cloud-based          that record critical data for
                                                                                       among obese and overweight                  Wearables equipped with             accessibility. Eventually,           medical treatment are being
                                                                                         people who keep a track of                electrocardiograph (EKG)            doctors will be comforted by         meticulously reviewed. Abbott
                                                                                        their changing body weight.                sensors can monitor the             growing accuracy of remote           Diabetes Care Inc. developed
                                                                                                                                   patient’s heart activity by         monitoring offered through           the FreeStyle Libre Flash
                                                                                                                                   sensing multiple physiological      wearable medical devices and         Glucose Monitoring System, a
                                                                                                                                   signals. Similar to the EKG         will formulate their therapy by      wearable arm patch for diabetes
                                                                                                                                   sensors, manufacturers of           thoroughly relying on the data       self-management. Initially,



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