Alphabet’s Verily has been working on the Study Watch since April of 2017 and now it’s electrocardiogram (ECG) technology has received Food and Drug Administration (FDA) approval, allowing the watch to be used as a Class II medical device. The prescription-only watch has been used in a number of trials including Project Baseline which is aiming to get a more accurate and representative baseline readings across a range of demographics, Aurora study which is focused on post-traumatic stress disorder, and the Personalized Parkinson’s Project.
In the blog post, Verily stated:
“We’re excited to announce that the Verily Study Watch has received 510(k) clearance from the U.S. FDA as a Class II medical device for its on-demand ECG feature. Specifically, the FDA-cleared Study Watch is a prescription-only device 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.”
Apple has integrated an ECG in its Apple Watch Series 4, and the inclusion of an ECG into Verily’s Study Watch could suggest that an upcoming smartwatch from Google may also include the technology, especially following its $40 million acquisition of Fossil’s smartwatch technology.