The FDA announcement, last updated Jan. 20, did not include additional information. The agency cleared ECG capabilities on the Study Watch in January 2019.
Launched in April 2017, the Study Watch has found use among thousands of people participating in clinical trials, according to Verily. The company touts the Study Watch’s unobtrusive biosensing, which includes built-in biometric, environmental and movement sensors.
Pharmaceutical industry giants including Novartis, Otsuka, Pfizer and Sanofi formed a strategic alliance with Verily last year to develop patient-centered clinical research programs using Verily’s Project Baseline evidence generation platform and tools, including the Study Watch.