Biotricity Requests 510(k) Clearance for Holter Monitor

Biotricity announced that it has applied to the FDA for 510(k) marketing clearance for its three-channel holter monitor, a portable device for cardiac monitoring.

The Biotres holter patch offers three-channel recording of electrocardiogram data and features a rechargeable battery, allowing it to be worn for two days before needing a one-hour charge.

The patch is fitted with wireless capabilities to transmit cardiac data for diagnoses using Bluetooth. The company said it expects the FDA’s review to take at least four months.