Alphabet's health division, Verily, has received FDA 510 (k) clearance for its smart watch for an Study "on-demand ECG feature." The Study Watch, announced in April 2017, is note a consumer smartwatch, but instead it means a test platform for the Google adjacent company to research how to gather health data on a wearable.
Back when it was announced, Verily said that it had an ECG feature alongside the usual things that you expect from a smartwatch but did not receive clearance from the FDA for it until today (oddly, in the midst of a government shutdown).
When Apple announced its electrocardiogram feature for the Apple Watch, it seemed like a completely unique and differentiating feature. Now, it's starting to feel like an ECG is about becoming a bog-standard component on lots of smartwatches. We saw it show up at CES on the Withs Move and a promise that it could be used for biometric identification on a Motiv ring.
It's important to note that the FDA "clearance" as a Class II device is very different from FDA "approval," which is typically reserved for Class III devices. The difference, as The VergeAngela Chen explained when the Apple Watch received its clearance, that the FDA isn't making any judgments on the actual efficacy of the devices, only that it's safe to use:
For Class II and Class I, the FDA doesn't give "approval," it just gives clearance. Class I and Class II products are lower risk products – as Speer puts it, a classic Class is like tongue depressor – and it's easier to get clearance than approval.
The Verily 's Study Watch was like I was looking for a more compelling product than smartwatches running Google' s Wear OS platform – if only because it has an e – ink screen and the better battery life that goes with it. Nevertheless, Verily is only using studies like Project Baseline, Aurora, and others.
Unlike the Apple Watch, the Study Watch is "a prescription-only device," though it does use the same "single-lead" method to measure EKGs. Single leads are less accurate than a full test office, but it potentially has use as a screening tool. Even in those limited use cases, though, false positives are still a concern for some doctors. Verily says that the ECG features a "single point channel record, store, transfer, and display ECG rhythm, and is a unique way to record, store, and health conscious individuals, and health conscious individuals "
You can probably get more FDA devices for clearing in the coming months and years. Back in 2017, the FDA announced a new pre-certification program along with a bunch of tech companies – clearly with an eye towards getting more cleared devices. Alongside Apple and Verily, Samsung, and a few other companies as part of the pilot.