Verily, Alphabet’s research organization devoted to the study of life sciences, has received FDA 510(k) clearance for its Study smartwatch. The prescription-only Study Watch, which was announced in April 2017, isn’t an ordinary smartwatch but is meant for medical research. One of the focus areas for Alphabet’s health division and its Study Watch is cardiovascular health, and the FDA clearance has now given its efforts in that department more legitimacy.
“Most cardiovascular events are preventable and the American Heart Association (AHA) has a stated goal of advancing mobile health to enhance prevention and care2. 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,” said verily.
“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,” Verily added in a blog post.
The Study Watch will also be a part of Verily’s “Baseline” study, which aims to track 10,000 participants over five years. The company hopes the results will help to better understand aging and disease. Verily also has other ambitious projects like glucose-tracking contact lenses, nanoparticle pills for detecting cancer and heart attacks, and bioelectronic medicines, reports MedGadget.