The Apple Watch’s atrial fibrillation (AFib) history feature has qualified for the FDA’s Medical Device Development Tools (MDDT) program, meaning it can now be used in clinical studies to help develop and evaluate medical devices.
This represents the first time a digital health tool has qualified for the MDDT program. Researchers now have a “non-invasive way to check estimates of AFib burden within clinical studies,” the agency said. It will specifically provide value by evaluating AFib estimates before and after the use of cardiac ablation devices.
When a tool qualifies for the MDDT program, it means device manufacturers know they can use it when developing and evaluating their own offerings. Other examples include the Kansas City Cardiomyopathy Questionnaire and the University of California San Francisco Lethal Arrhythmia Database.
The program categorizes these tools into one of three categories:
- Non-clinical assessment models measure or predict “parameters of interest” related to device safety, effectiveness or performance.
- Biomarker tests detect or measure specific biomarkers.
- Clinical outcome assessments focus on how a person feels or function. This can be reported by healthcare providers, clinical observers or the person themself. These assessments can be collected in a physical clinic or remotely.
The Apple Watch’s AFib history feature qualified as a biomarker test.
“Any tool developer, medical device sponsor or others, such as research organizations and academia, can voluntarily submit a proposal,” the FDA explained on its website. “The program aims to provide MDDT developers and medical device sponsors with a mechanism for discussing early concepts about a tool, and facilitating increased adoption and use of qualified tools.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.