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
Access to all functions is reserved for healthcare personnel.
If you are a healthcare professional, you must log in or register for free on our site to access all of our content.
If you are a journalist or want to inform us, write to us at [email protected].
1715161697
#FDA #validates #Apple #Watch #Heart #Tracker #clinical #trials
