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Biotricity Granted FDA’s 510(k) Clearance for Its Biotres Cardiac Monitoring Device

January 28, 2022

Biotricity has received 510(k) clearance from the FDA for its Biotres cardiac monitoring device, a three-lead device for electrocardiogram (ECG) and arrhythmia monitoring intended for lower-risk patients.

The modular device, which offers continuous three-channel recording of ECG data via a wearable holter patch, has a rechargeable battery and wireless connectivity.

The Redwood City, Calif.-based company says the Biotres device will be available in the U.S. starting April 1.

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