Alphabet’s ECG Watch Gets FDA Clearance

Verily’s prescription-only smart watch just received clearance from the FDA amidst the government shutdown.

Study Watch / Image: Verily
Study Watch / Image: Verily

A recent article from The Verge just reported that Verily, Alphabet’s health division, received FDA 510(k) clearance for the on-demand ECG feature on its Study smart watch. The device was announced back in April of 2017 as a test platform to determine the best method for gathering health data on a wearable device. It should be noted that the watch received FDA “clearance” as a Class II device, which is different from FDA “approval,” which is typically reserved for Class III devices.

The Study Watch uses a “single-lead” method for measuring ECGs, which are less accurate than the version you’d receive in a medical office. Verily says the Study Watch 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.”

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