FDA Approves ECG Device, Verily Study Watch

The US Food and Drug Administration (FDA) has approved Verily’s Study Watch, a wearable medical device that conducts electrocardiograms (ECGs), which measure electrical activity of the heart and can be used to diagnose a number of heart conditions.

The FDA granted a 510(k) clearance to the watch, classifying it as a Class II medical device for its on-demand ECG feature, which records, stores, transfers, and displays single-channel ECG rhythms. Additionally, the watch is a prescription-only device intended for use by healthcare professionals, adult patients with known or suspected heart conditions, and health conscious individuals.

Since Verily launched its Study Watch in April of 2017, the investigational device has been used by thousands of participants in clinical trials. Studies have been conducted by the Project Baseline study, Aurora study, Personalized Parkinson’s Project study, and Parkinson’s Progression Markers Initiative.

With devices like Verily’s Study Watch, unobtrusive biosensing offers a novel approach to understanding bodily functions, as well as disease progression, at any given point in time. In addition, Study Watch can broadly contribute to research efforts with its built-in biometric, environmental, and movement sensors.

By offering mobile health to help enhance current and preventative care, Study Watch contributes efforts to cardiovascular health and diseases like heart disease, which is the number 1 killer of men and women in the United States. Since heart disease has well-understood signals that indicate disease risk and the risk of a future event, an on-demand, single-lead ECG

in real-time via mobile access offers a new approach to clinical care and population-based research.

The FDA approval of Verily’s Study Watch adds to the growing market of cardiovascular devices, such as AliveCor’s KardiaBand that was approved by the FDA in 2017. KardiaBand was the first medical-grade accessory for Apple Watch to quickly detect normal sinus heart rhythms and atrial fibrillation via ECG measurements.

With the KardiaBand approval, AliveCor also introduced SmartRhythm, a new feature within the Kardia app that uses artificial intelligence with inputs from Apple Watch’s heart rate and activity sensors to continuously evaluate the correlation between heart activity and physical activity. When the feature detects an abnormal heart beat, the device notifies users to capture EKG data.

Speaking on the KardiaBand approval in 2017, Ronald Karlsberg, MD, FACC, board certified cardiologist, clinical professor of medicine, Cedars Sinai Heart Institute, David Geffen School of Medicine, UCLA, emphasized how mobile devices are improving and shifting healthcare.

“This is a paradigm shift for cardiac care as well as an important advance in healthcare,” he said in a statement. “EKGs are available only in offices and hospitals, using complex equipment, and usually only after a life-threatening event, for example a stroke.”

Verily did not respond to requests for comment at the time of publication.