Verily’s Study smart watch has obtained 510(k) clearance from USFDA (U.S Food and Drug Administration) for its feature of “on-demand ECG”. This watch was firstly publicized in April 2017. It is not for consumers but for a research on best way to gather personal health information using a wearable. That means it is used as a test platform.
Though it had that ECG feature along with the normal things that an ordinary smartwatch does have at its initial announcement, it did not get the FDA clearance until 18th of January, 2019.
When the electrocardiogram feature of Apple’s smart watch was announced, it looked like an entirely unique and also distinguishing feature. But at present, EKG is becoming an ordinary, basic feature of a smartwatch. At CES, Withings’ introduced their new smartwatch with EKG and Motiv promised that they will introduce EKG feature to their fitness ring in near future.
When FDA gave clearance for Apple smartwatch it only considered about its safety to use, but now it considers about device’s actual efficacy also. Therefore there can be found huge difference between FDA “clearance” and FDA “approval”.
When it was 1st announced Verily’s Study smart watch caught sudden attention as potential replacement for current Google smart watches which runs on Google’s Wear OS platform. Main reason was that Verily’s Study smart watch equipped with e-ink screen and extended battery life. However Study smart watch only using in studies such as Project Baseline, Aurora and several others.
Verily’s Study smart watch is a prescription-only device unlike Apple watch, even though they both contain same “single-lead” technology to measure EKGs. Single lead method is less accurate than full test that conducted in medical office, however it can use as potential screening tool. But even in some specific situation some doctors still have some concerns towards false positives. Verily states that EKG feature on Study watch is “intended to record, store, transfer, and display single-channel ECG rhythms, and is indicated for use by healthcare professionals, adult patients with known or suspected heart conditions, and health conscious individuals”.
You can expect many devices to introduce within next couple years even within months after getting FDA approval. In 2017 FDA announced new pre- certification program alongside with several tech companies to speed up the clearing process in order to introduce new devices. According to FDA, currently FDA working with several other companies such as Fitbit, Samsung alongside with Apple and Verily as part of the pilot.