FDA Clears Verily's Prescription-Only ECG Smartwatch
The FDA clears Verily's Study Watch for on-demand ECG recording as a prescription-only medical device.
The FDA clears Verily's Study Watch for on-demand electrocardiogram (ECG) recording, officially classifying the Google life sciences subsidiary's smartwatch as a regulated medical device. The prescription-only wearable allows users to record a single-lead ECG simply by placing a finger on the watch's sensor to monitor their heart rhythm.
Unlike consumer electronics, Verily designs this specific smartwatch exclusively for clinical research use rather than direct sale to the general public. Researchers conducting clinical trials rely on this targeted approach to gather accurate medical data, requiring patients to obtain the device through a prescription from their healthcare provider.
This regulatory clearance places Verily in direct competition with the Apple Watch Series 4, which boasts similar FDA-cleared ECG capabilities. However, while Apple targets everyday consumers with its health features, Verily maintains a strict focus on the medical research community to support advanced clinical studies.