BRUSSELS – FibriCheck, a mobile app for heart rhythm disorders, has received clearance from the U.S. Food and Drug Administration. The app uses the camera of a smartphone or the optical sensors of a smartwatch to detect atrial fibrillation. “Receiving FDA clearance for a software-only application using consumer devices was a difficult challenge and demonstrates the competence and the excellence of our team,” said Lars Grietenm, CEO and co-founder of FibriCheck, in a statement. “Having all knowledge in-house, it serves as a foundation to expand our product development roadmap beyond the smartphone and look into continuous monitoring.” Grietenm said the FibriCheck FDA clearance is the first such clearance for a smartphone app to detect heart rhythm disorders without using any external medical devices. The user places their finger on the camera of the smartphone, which measures the light reflection caused by the blood that is flowing in the fingertip.
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