FDA OKs ECG Feature on Verily Study Watch for Research

Megan Brooks

January 21, 2019

Alphabet's health research division, Verily, has received 510(k) clearance from the US Food and Drug Administration (FDA) for the on-demand electrocardiogram (ECG) feature on its smartwatch, the company has announced.

The Verily Study Watch was launched in April 2017 as an investigational device for capturing a wide range of health information from clinical research participants. The ECG feature on the watch received FDA clearance January 18.

The Verily Study Watch is a class II prescription-only medical device intended to record, store, transfer, and display single-channel ECG data, and "is indicated for use by healthcare professionals, adult patients with known or suspected heart conditions, and health-conscious individuals," according to Verily.

This is notable because the Apple Watch's irregular heart rhythm notifications are not intended for people who have been diagnosed with atrial fibrillation.

"The ability to take an on-demand, single-lead ECG can support both population-based research and an individual's clinical care. Receiving this clearance showcases our commitment to the high standards of the FDA for safety and effectiveness and will help us advance the application of Study Watch in various disease areas and future indications," Michael V. McConnell, MD, Verily's head of cardiovascular health innovations, said in a blog post.

Since being launched, the watch has been used by thousands of participants in clinical research studies run by Verily and its partners, which include Duke University School of Medicine, Stanford Medicine, Brigham and Women's Hospital, Sanofi, GlaxoSmithKline, and Biogen. Among the studies are Project Baseline, the Aurora study of post-traumatic stress, the Personalized Parkinson's Project, and the Parkinson's Progression Markers Initiative.

Cardiovascular health has been one area of focus for the Study Watch, as heart disease remains the top cause of premature death in men and women in the United States, McConnell reported.

"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," he said.

"Together, we are working toward a future where we can use devices, like the FDA-cleared Study Watch, to inform real-world, personalized-care decisions and help us move to proactive healthcare," he added.

Medscape editor-in-chief, Eric Topol, MD, is an adviser for Verily.

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