Verily's smartwatch gets FDA clearance for EKG: 4 things to know

The FDA has cleared the Verily Study Watch as a prescription-only device to record, store, transfer and display wearers' heart rhythms via an on-demand electrocardiogram feature, the company wrote in a Jan. 18 blog post.

Four things to know:

1. The FDA's 510(k) clearance classifies the Verily Study Watch as a Class II medical device intended for use by healthcare professionals, adult patients with known heart conditions and health conscious individuals, the post reads.

2. Verily launched the smartwatch in April 2017 as an "investigational device for capturing health information from clinical research participants while serving as an easy-to-read watch for daily wear," the company notes. It uses built-in biometric, environmental and movement sensors to track wearers' health in real-time.

3. The Verily Study Watch has been used in several research projects since its launch, including Project Baseline, Aurora and Personalized Parkinson's Project. Cardiovascular health has become a growing area of interest for Verily.

"The ability to take an on-demand, single-lead ECG, can support both population-based research and an individual's clinical care," the post reads. "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. We look forward to embarking on additional research explorations focused on cardiovascular health."

  • 4. The Verily Study Watch team hopes that its research projects that collect patient-generated health data will "ultimately give us insights into the utility of integrating mobile health data into the clinical care environment, and how these data can support the physician-patient relationship."
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