Alphabet’s health division gets FDA clearance to test EKG smartwatch feature

Alphabet’s health department Verily has been granted the FDA 510 (k) as a smart watch for research for “on-demand ECG function”. The Study Watch, released in April 2017 is not a consumer smartwatch, but a testing platform for Google’s neighbor companies to study how best to gather health data from wearables.

When it was announced, Verily said that you have ECG features with the usual things you expect from a smartwatch, but it has not been approved by the FDA to this day (strangely, in the middle of the government).

When Apple announced the Apple Watch electrocardiogram function, it looked like a completely unique and differentiating function. Now EKGs are beginning to feel like being a bog-standard component in many smartwatches. We have seen the promise that it can be used for biometrics in the CES of the Withings Move and the future Motiv ring.

A Class II device, the FDA “Clearance” is very different from the FDA. It is normally “approved” for Class III devices. The difference is Angela Chen of The Verge only explained that when Apple Watch was licensed, it was safe for the FDA to use it without judging the actual efficacy of the device.

For Class II and Class I, the FDA is only authorized without “approval”. Class I and Class II products are low risk products, as Speer said, the classic Class I example is like a tongue depressor.

Verily’s Study Watch was remarkable. It was first announced because it seemed to be more attractive than smart watches running on Google’s Wear OS platform because of the longer battery life that goes with the electronic ink screen. Nonetheless, Verily uses it only in Project Baseline and Aurora research.

Unlike Apple Watch, Study Watch uses the same “single lead” approach to measuring EKG, but is a “prescription-only device.” A single lead is less accurate than a full test available in a medical office, but is potentially used as a screening tool. Even with limited use cases, false positives are still a concern of some doctors.

Verily’s Study Watch’s EKG function is intended to “record, store, transmit, and display single-channel ECG rhythms and be used by health care professionals, adult patients with suspected or suspected heart disease, and health-conscious individuals” [19659008] In the coming months and years, more devices can expect to remove the FDA. Going back to 2017, the FDA turned its attention to eliminating more devices and announced a new pre-certification program with many technology companies. Together with Apple and Verily, the FDA said it is working with Fitbit, Samsung and several other companies as part of its pilots.

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