Alphabet‘s life sciences group Verily has secured 510(k) clearance from the FDA for Study Watch for an on-demand electrocardiogram (ECG) feature.
The FDA-approved Study Watch is a prescription-only device aimed to record, store, transfer and display single-channel ECG rhythms.
It is suggested for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.
Verily head of cardiovascular health innovations Michael McConnell said in a blogpost, “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.”
Verily Study Watch, which was introduced in April 2017, is an investigational device aimed to capture health information from clinical research participants. It also serves as an easy-to-read watch for daily wear.
Since its launch, Study Watch has been used by several participants in clinical research studies run by Verily and through its partners.
The architecture of Study Watch has been designed specifically for high quality signals and better usage.
Verily Study Watch features several physiological and environmental sensors, A long battery life of up to one week; large internal storage and data compression.
The investigational device stores health data, all data are encrypted on the device for security. The encrypted data are uploaded and processed in the cloud using Verily’s backend algorithms and machine learning tools.
Verily said it is 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.
McConnell said: “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.”