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SMARTWATCHES AS A MEDICAL DEVICE?



Of the $70bn wearable technology market in 2019, $20bn in revenue came from wearable medical devices! Wearable electronic devices are an excellent option for detecting the physiological parameters of the wearer. From low-range cardio fitness, walking speed, pulse oximetry, to ECG monitoring and more!


Traditionally, medical and non-medical products have been clearly separated along dividing lines in the form of regulatory barriers. However, the introduction of increasingly sophisticated physiological monitoring techniques into products such as smartwatches indicates increasing encroachment towards and over this line, bringing traditional consumer product companies towards the realm of medical devices.


Apple announced the latest features that will be added to the Apple Watch in watchOS 7. Amongst these were expanded capabilities of the health app, including new "mobility metrics" such as low-range cardio fitness, walking speed, stair-descent speed, stair-ascent speed, six-minute walk distance, double support time, step length, and asymmetry. The most prominent medical feature on the Apple's market leading smartwatch was the ECG monitoring introduced with the Apple Watch 4 in late 2018. Apple gained FDA Class II clearance for the ability to detect and notify the user of irregular heart rhythm, and an ECG app which could be used to identify potential signs of atrial fibrillation.


Garmin's acquisition of leading physiological analytics company Firstbeat. They have provided the core technology used by Garmin and others for metrics in the areas of stress, sleep, VO2 max, training status/load, training effect, respiration rate, calories burned and much more. Firstbeat epitomises the best of what is available on the "fitness" side of the divide, and the acquisition by Garmin following over a decade of previous relationship emphasises the strategic importance of their work.


For the majority of medical devices, regulatory approval or clearance is an essential prerequisite to commercial sales. However, smartwatches now join groups of other products which exist on the boundary where choosing whether or not to seek formal medical device approvals is a more complicated strategic decision

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