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Medical Devices / Submissions and Approvals

FDA Clears Verily’s ECG Device

Jan. 23, 2019

Alphabet subsidiary Verily’s Study Watch received 510(k) clearance for its electrocardiogram feature, allowing the device to record a patient’s ECG rhythms.

The wearable device can store, transfer and display single-channel ECG rhythms and is indicated for use by healthcare professionals, health conscious patients and adults with heart conditions.

The device enables the scalable collection of data in clinical and observational studies. It has previously been used in clinical trials to capture participants’ health information.

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