2024-05-08 09:39:44
Apple Watch’s atrial fibrillation monitoring tool recently received approval from the Food and Drug Administration (FDA) for use in clinical trials.
This qualification is part of the FDA’s Medical Device Development Tools (MDDT) program, a voluntary program that evaluates devices for use in medical research. The clock functionality is designed to serve in clinical trials as a biomarker test to determine atrial fibrillation burden, a critical endpoint for the safety and effectiveness of atrial fibrillation ablation devices. It tracks the frequency of atrial fibrillation episodes in patients on a weekly basis.
This approval represents a significant step forward for the integration of digital technologies in medical research
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