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