FDA clears Verily's prescription-only ECG smartwatch

Verily, the Alphabet research division formerly known as Google Life Sciences, has received a 510(k) clearance from the FDA for its own clinical study smartwatch, complete with an on-demand ECG. But as a prescription-only device, it’s far from a competitor to Apple’s publicly available smartwatch.

Verily’s Study Watch was first launched as an investigational device in April 2017 to help capture health information from participants in studies such as Project Baseline—a longitudinal venture by Google, Stanford Medicine and Duke University that aims to track 10,000 volunteers for four years using a variety of metrics.

The FDA cleared a new version of the watch as a class II device for adults, including those with known or suspected heart conditions, for use as a single-lead ECG.

“One area of focus for Study Watch has been cardiovascular health, as heart disease remains the No. 1 killer of men and women in the United States,” Verily’s cardiovascular health innovations head, Michael McConnell, wrote in a company blog post.

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“This work may ultimately give us insights into the utility of integrating mobile health data into the clinical care environment, and how these data can support the physician-patient relationship,” McConnell said. Verily plans use both the investigational and the FDA-cleared versions in studies going forward.

Verily recently announced a $1 billion investment round to catapult new global partnerships, business development and potential acquisitions.

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“We are taking external funding to increase flexibility and optionality as we expand on our core strategic focus areas,” Verily CEO Andrew Conrad said at the time. “Adding a well-rounded group of seasoned investors, led by Silver Lake, will further prepare us to execute as healthcare continues the shift towards evidence generation and value-based reimbursement models.”