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Medical Devices / Submissions and Approvals

FDA Clears Biotricity ECG Remote Monitoring Device

Dec. 28, 2017
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Medical diagnostic firm Biotricity received FDA 510(k) clearance for Bioflux, its ECG remote monitoring device.

The device features viewing software, detects and transmits diagnostic heart information, including probable arrhythmias, to physicians to allow for remote monitoring and diagnosing of patients with cardiovascular coronary heart disease.

The company said it plans to develop other disease-specific remote biometric technologies to help diagnose, treat, and manage chronic diseases.

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