Fierce Biotech May 6, 2024
The FDA has handed a groundbreaking green light to the Apple Watch, allowing its atrial fibrillation tracking features to be employed in clinical studies.
The watch’s sensor and software marked the first digital health product to be qualified under the agency’s Medical Device Development Tools program—a voluntary pathway that deems certain technologies as reliable enough to be employed in scientific research without needing additional review.
The program has previously given the thumbs-up to cardiovascular disease questionnaires for measuring quality of life, as well as imaging programs that help screen for patients who may be eligible for a study, among other tools.
Now, the Apple Watch joins the list as a biomarker test that can help estimate a patient’s burden of...
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