California: After Apple, Google’s parent company Alphabet is working its way towards bringing health at the center of its products. Now, the company’s health division Verily has reportedly received FDA 510(k) clearance for its Study smartwatch for an on-demand ECG feature.
The Study Watch, announced two years ago, is intended to be a test platform for the company to research how to best gather health data on a wearable device, The Verge reported.
The smartwatch already had the ECG feature, however, it didn’t receive clearance from the FDA. The feature is increasingly becoming a standard for a lot of manufacturers and FDA’s clearance for the feature in a Class II device is not for the actual efficacy of the device, but only that it is safe to use.
Alphabet’s Study Watch is a prescription-only device and is not meant to be a consumer smartwatch. The EKG feature on the Study Watch is intended to record, store, transfer, and display single-channel ECG rhythms.
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