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FDA clears ECG feature on Verily Study Watch for medical research

Verily has a number of ongoing hardware projects from smart contact lenses to miniaturized continuous glucose monitors. Alphabet’s health division is also working on a Study Watch that was just granted ECG clearance by the FDA.

As the name suggests, the Verily Study Watch is intended for collecting data as part of research programs rather than as a consumer device, like the Apple Watch or a Fitbit. Announced in 2017, it can record electrocardiogram (ECG), heart rate, electrodermal activity, and inertial movements. Devices are given and used to track participants of Verily’s Precision medicine projects, like Baseline, Parkinson’s, and PTSD.

Unobtrusive biosensing through devices like Study Watch and other mobile health tools is an important new approach to understanding what happens in the body at any given moment in time, and can provide insights into how our bodies stay healthy or change and adapt with disease. With built-in biometric, environmental and movement sensors, Study Watch can contribute to research efforts broadly.

The 510(k) clearance from the U.S. Food and Drug Administration classifies the Study Watch as a Class II medical device for the on-demand ECG feature. Electrocardiograms measure the electrical activity of the heart and can help diagnose the future risk of heart conditions.

Specifically, the FDA-cleared Study Watch is a prescription-only device intended to record, store, transfer and display single-channel ECG rhythms, and is indicated for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.

Other features of the Verily device include an E-Ink display allowing for week-long battery life and an always-on screen that notes the time. Its processor allows for real-time on-device algorithms, with data compression allowing for weeks’ worth of raw data that is encrypted. The investigational Study Watch also supports OTA updates that can load new algorithms and UI features.


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Avatar for Abner Li Abner Li

Editor-in-chief. Interested in the minutiae of Google and Alphabet. Tips/talk: abner@9to5g.com