FibriCheck’s Heart Monitor App Cleared by FDA

October 11, 2018

The FDA granted 510(k) clearance for FibriCheck’s heart monitor smartphone application, which is used to detect issues with the user’s heart rhythms.

FibriCheck’s app — which is expected to be launched on the U.S. market in 2019 — uses the phone’s camera and software to monitor patients for heart rhythm disorders.

The app scans for atrial fibrillation in the patient by monitoring and measuring their heart rhythm through photoplethysmography — a low-cost technique that detects blood volume changes — and a built-in algorithm.

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