Verily Study Watch Receives FDA 510(k) Clearance for ECG
In late 2018, Apple received FDA Clearance for their ECG app on the Apple Watch Series 4.
Now Verily, part of Google's parent company, Alphabet, announced that the Verily Study Watch has received 510(k) clearance from the FDA as a Class II medical device for its on-demand ECG feature.
According to Verily, the FDA-cleared Study Watch is a prescription-only device that can take an on-demand single-lead ECG, and is indicated for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.
"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," Verily wrote in a blog post. "We look forward to embarking on additional research explorations focused on cardiovascular health."
Verily launched Verily Study Watch in April 2017 as 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 their 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. Most cardiovascular events are preventable and the American Heart Association (AHA) has a stated goal of advancing mobile health to enhance prevention and care.
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.
Through Verily's current research, including longitudinal studies like Project Baseline, they 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 Verily insights into the utility of integrating mobile health data into the clinical care environment, and how these data can support the physician-patient relationship.
The trend for smartwatches is clearly moving towards ECG integration and even blood pressure monitoring as Omron recently announced their smartwatch. 2019 should be exciting for smartwatches and wearables as a number of entrants will be launching devices with similar capabilities as the Google and Apple watches.