The US Food and Drug Administration (FDA) has cleared Google sister company Verily’s Study Watch for its ECG feature to record, store, transfer and display single-channel ECG rhythms.
Classified as a class II medical device, the prescription-only watch can be used by healthcare professionals as well as adults with known or suspected heart conditions.
Launched in 2017, the Verily Study Watch is being used in multiple projects to collect health information from clinical research participants.
The Project Baseline, being conducted in alliance with Duke University School of Medicine , Stanford Medicine and Google, aims to use the wearable device to gain better insights into how to prevent diseases.
In the AURORA study, Verily is working with several partners to identify predictive and diagnostic biomarkers, as well as preventive/treatment approaches for veterans and trauma survivors.
A multi-year study, Personalized Parkinson’s Project is using the Verily Study Watch along with molecular analyses, advanced brain imaging and other wearable devices for in-depth disease analysis.
In addition, Verily is participating in the Parkinson’s Progression Markers Initiative (PPMI) study to detect the disease biomarkers using advanced imaging, biologic sampling, and clinical and behavioural evaluations.
The Verily Study Watch is additionally focussed on cardiovascular health. By monitoring ECG, the device is expected to help diagnose a variety of heart conditions.
A statement from Verily read: “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.”
The company is planning to conduct additional research on cardiovascular health.
Earlier this month, Verily raised $1bn to support investments in strategic alliances, global business development opportunities and potential acquisitions.