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Verily, the health division of Alphabet, has received 510 (k) clearance from the FDA for its Study Smart Watch with an on-demand ECG feature. This study, announced in April 2017, is do not A smart watch for consumers, but rather a test platform allowing the company adjacent to Google to find the best way to collect health data on a laptop.
When it was announced, Verily said it had an ECG function alongside the usual elements of a smartwatch – but the FDA had not given the green light to activate it (today, strangely, in full closure of the government).
When Apple announced its electrocardiogram function for the Apple Watch, it seemed to be a very unique and differentiating feature. Now, it is starting to feel like the electrocardiogram is about to become a standard component for many smartwatches. We saw it appear at CES on the Withings movement and a promise that it could be used for biometric identification on a future Motiv ring.
It is important to note that the "game" of the FDA as a Clbad II device is very different from the "approval" of the FDA, which is generally reserved for Clbad III devices. The difference, as The edgeAngela Chen explained when approving the Apple Watch, that the FDA was not pronouncing on the actual effectiveness of the device, but simply that it could be used safely:
For Clbades II and I, the FDA does not grant "approval", it simply gives an authorization. Clbad I and Clbad II products are low-risk products – as Speer says, a clbadic Clbad I example looks like a tongue depressor – and it's much easier to get approval than to approve.
Verily's study watch was remarkable when it was announced because, in some ways, it seemed to be a more convincing product than the smartwatches running on the Google Wear OS platform, if only because it has an electronic ink screen and a better autonomy that results. Nevertheless, Verily only uses it in studies such as Project Baseline, Aurora and others.
Unlike the Apple Watch, the Study Watch is "a prescription only device" although it uses the same "one-driver" method for measuring ECGs. Single probes are less accurate than the full test that you can get in a doctor's office, but it is potentially useful as a screening tool. Even in these limited use cases, some fake doctors remain a concern. Truthfully, the Study Watch EKG feature is "designed to record, store, transfer, and display single-channel ECG rhythms and is indicated for healthcare professionals, adult patients with known or suspected heart problems, and people who are concerned about their health. "
You can probably expect many other devices to get FDA clearance in the months and years to come. In 2017, the FDA announced a new pre-certification program as well as many technology companies, clearly in the interest of seeing other approved devices. Along with Apple and Verily, the FDA said it was working with Fitbit, Samsung and a few other companies as part of the pilot project.
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