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Verily Study Watch Receives FDA 510(k) Clearance for ECG
Friday, January 18, 2019
In April of 2017, we
launched
Verily Study Watch, an investigational device for capturing health information from clinical research participants while serving as an easy-to-read watch for daily wear. Since then, Study Watch has been used by thousands of participants in clinical research studies run by Verily and through our partners, such as the
Project Baseline
study,
Aurora
study,
Personalized Parkinson’s Project
study, and
Parkinson’s Progression Markers Initiative
. Unobtrusive biosensing through devices like Study Watch and other mobile health tools is an important new approach to understanding what happens in the body at any given moment in time, and can provide insights into how our bodies stay healthy or change and adapt with disease. With built-in biometric, environmental and movement sensors, Study Watch can contribute to research efforts broadly.
One area of focus for Study Watch has been cardiovascular health, as heart disease remains the number one killer of men and women in the United States
1
. Most cardiovascular events are preventable and the American Heart Association (AHA) has a stated goal of advancing mobile health to enhance prevention and care
2
. The good news is there are well-understood signals that can indicate heart disease and the risk of a future event. The electrocardiogram, or ECG, is a measurement of the electrical activity of the heart and is useful in diagnosing a myriad of heart conditions.
Therefore, we’re excited to announce that the Verily Study Watch has received 510(k) clearance from the U.S. Food and Drug Administration (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. 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. We look forward to embarking on additional research explorations focused on cardiovascular health.
Through our current research, including longitudinal studies like Project Baseline, we are working to collect and organize many types of health data, from biometric data like ECG to genomic and proteomic data to traditional clinical data, such as electronic health records and medical images. 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. Our collaborative team of clinical and data scientists, engineers, regulatory and legal experts, user experience designers and more are helping us pursue this vision. Together, we are working towards 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.
Posted by Michael V. McConnell, MD, MSEE, Head of Cardiovascular Health Innovations, Verily; Clinical Professor of Medicine, Stanford University School of Medicine; Member of the AHA Health Technologies Advisory Group
1
Heart Disease (2017, November 28). National Center for Chronic Disease Prevention and Health Promotion, Division for Heart Disease and Stroke Prevention. Retrieved from
https://www.cdc.gov/heartdisease/facts.htm
.
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2
Eapen ZJ, Turakhia MP, McConnell MV, Graham G, Dunn P, Tiner C, Rich C, Harrington RA, Peterson ED, Wayte P. Defining a Mobile Health Roadmap for Cardiovascular Health and Disease. J Am Heart Assoc. 2016 Jul 12; 5(7).
https://www.ahajournals.org/doi/10.1161/JAHA.115.003119
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