Alphabet Receives Clearance from FDA for Verily ECG Smartwatch
Last updated June 21, 2021
- Google’s parent company Alphabet is working on a new smartwatch.
- The smartwatch was approved by the FDA with a 510(k) clearance to include an ECG.
- The product will be used for collecting health data and will not be made available commercially.
One of the highlight features of the new Apple Watch that came out last year was a built-in ECG. Alphabet may be working on something similar with the company receiving an FDA 510(k) clearance for its “Study” smartwatch. The Study Watch was first announced in April 2017, and unfortunately, it is not a product meant for consumers.
Alphabet’s smartwatch is designed to help the company research data gathering methods in the field of healthcare. The ECG feature was announced last year, but the clearance from the FDA was not available until now. One of the key takeaways for consumers is that the ECGs are by no means approved by the FDA for usage over standard healthcare practices, the “FDA-cleared” tag simply implies that they are safe for usage.
The Study Watch by Alphabet is said to be a prescription-only device despite using the same ECG technology as Apple. It makes use of a single lead method which is far less accurate than what a full testing method utilizes. According to the manufacturer the device 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.”
With the Apple Watch and Alphabet Study Watch being approved by the FDA it is likely that other manufacturers will apply for approval as well in the near future. To accommodate healthcare features in technology, the FDA had implemented a new certification process that enables more devices to get cleared, and manufacturers like Samsung and Fitbit have already taken advantage of it for their products. It remains to be seen if Alphabet will be moving to the consumer market with its smartwatches or if the Study Watch will remain an internal affair only.
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