FDA approves Verily’s Study Watch to monitor cardiovascular conditions
Verily Life Sciences has received a new clearance from the Food and Drug Administration allowing the use of its Study Watch to monitor patients with cardiovascular conditions.
The federal agency provided a 510(k) clearance for the Study Watch with Irregular Pulse Monitor, enabling the device to be used with patients older than age 22 who have been diagnosed or are susceptible to atrial fibrillation, a quivering or irregular heartbeat (arrhythmia) that can cause blood clots, stroke, heart failure and other heart-related complications.
The watch enables users to monitor and record their heart rhythms, and it also can record, store, transfer and display single-channel electrocardiogram rhythms, according to Verily, a research organization of Alphabet that’s devoted to the study of life sciences.
About a year ago, the Study Watch—a sensor device designed to enable non-invasive continuous monitoring—received its initial clearance for the device for its use in performing electrocardiograms, a test that measures the electrical activity of the heartbeat.
The latest FDA clearance “validates our approach at Verily to building robust, clinical-grade tools and solutions that can support clinicians in delivering the highest level of care and improve self-management for patients,” the company said in announcing the FDA decision.
“With this new indication, (we) will explore opportunities to leverage Study Watch as a measure of irregular pulse in clinical settings across our cardiovascular programs, including our collaboration with iRhythm,” Verily added. Engineers are working with iRhythm’s Zio Service, which supports long-term continuous monitoring, data analytics and cloud-based machine learning to monitor atrial fibrillation.
Research using the Study Watch as a portable monitoring device is enabling scientists to capture more signals from the human body, generating evidence to support disease management programs, treatments and interventions.
The Study Watch primarily has been used in Verily’s own clinical research studies, but the company also is offering the technology to researchers outside the company, such as the Project Baseline study, Aurora study, Personalized Parkinson’s Project study and the Parkinson’s Progression Markers Initiative.
All of the research using Study Watch is under Project Baseline, which is Verily’s flagship clinical research program that launched in 2017. Collaborators of Project Baseline include Duke University School of Medicine, Stanford Medicine, Google and the American Heart Association. Verity further has brought in patients and patient advocacy groups, academic research institutions, healthcare delivery systems and life sciences development groups.