Three-lead Holter monitor for low-risk patients gains FDA 510(k) clearance
Biotricity announced it received 510(k) clearance from the FDA for its three-lead device for ECG and arrhythmia monitoring for use among lower risk patients.
“Biotres is a Holter for low-risk patients and is designed for comfort for long-term wear,” Waqaas Al-Siddiq, founder and CEO of Biotricity, said in a press release from the company. “Cardiac disease remains a chronic issue, requiring persistent intervention, monitoring and management, and we believe Biotres may provide a critical tool for improving patient lives and reducing costs.”
According to the release, the device includes a wearable Holter patch device that can provide continuous three-channel recording of ECG data; can be worn continuously for 48 hours before needing to be charged for 1 hour; and uses Bluetooth technology to offload data, which can reduce the time to diagnosis.
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