Monday , September 26 2022

The health division of the alphabet obtains the FDA authorization to test the intelligent viewing function of the EKG


The health division of the alphabet, in fact, has received the approval of the FDA 510 (k) for its intelligent study watch for a "ECG feature on demand." The Watch studio, announced in April 2017, is no a smart consumer monitor, but which means it is a trial platform for the adjacent Google company to investigate how to better collect health data in a usable material.

Back when it was announced, Verily said that he had an ECG feature along with the usual things he was expecting from an intelligent monitor, but he did not receive clearance from the FDA for this to date (strangely, in the middle of a government stop).

When Apple announced its function of the electrocardiogram for Apple Watch, it seemed a unique and differentiating feature. Now, it starts to feel like EKG is about to become a standard component of many smartphones. We saw CES at The Withings Move and a promise that could be used for biometric identification in the future Motiv ring.

It is important to note that the "liquidation" of the FDA as a class II device is very different from the approval of the FDA, which is normally reserved for Class III devices. The difference, how The virginAngela Chen explained when Apple Watch received her approval, is that the FDA does not make any judgment about the actual effectiveness of the device, it's just safe to use:

For class II and class I, the FDA does not "approve", it just ends up authorizing. Class I and Class II products are products of lesser risk, as Speer says, a classic class example is something like a language depressant, and it is much easier to obtain authorization than approval.

Verily's Study Watch was remarkable when it was announced for the first time because in some respects it seemed a more attractive product than smartwatches that were running the Google Wear OS platform, although it only had an electronic ink screen and the best service life of the battery However, Verily is only using it in studies such as Project Baseline, Aurora, and others.

Unlike the Apple Watch, Study Watch is "a single prescription device", although it uses the same method of one single advantage to measure EKG. Individual cables are less accurate than the full test you can get in a medical office, but it may be used as a detection tool. However, in those cases of limited use, false positives remain a concern for some doctors. He really says that the role of EKG in Study Watch is "designed to record, store, transfer and display single-channel ECG rates, and is indicated for use by health professionals, adult patients with known or suspected cardiovascular conditions and individuals aware of health. "

Probably, you can expect that many more devices will get the FDA removed in the coming months and years. Already in 2017, the FDA announced a new pre-certification program along with a group of technology companies, clearly aimed at getting more devices cleaned. Together with Apple and Verily, the FDA has said that it is working with Fitbit, Samsung and some other companies as part of the pilot.

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