The Apple Watch has recently been recognized by the Food and Drug Administration (FDA) with a qualification that positions the smartwatch as a valuable resource for medical device companies demonstrating the effectiveness of prevalent heart treatments.

Just last week, the Apple Watch's Atrial Fibrillation History feature was officially qualified under the FDA's Medical Device Development Tools (MDDT) program. Introduced in 2022, this feature provides estimates of a user's A-fib burden—the amount of time their heart remains in atrial fibrillation. Atrial fibrillation is a condition characterized by an irregular heartbeat that can lead to symptoms like shortness of breath and fatigue, and it increases the risk of stroke.

This FDA qualification indicates that the feature can now be used as a secondary endpoint in clinical trials, eliminating the need for additional validation. Specifically, the Apple Watch is approved to serve as a secondary endpoint in studies evaluating cardiac ablation devices. These devices aim to alleviate A-fib by using extreme heat or cold to create scars in the heart tissue that disrupt faulty electrical signals. The latest advancement in this technology, pulsed field ablation, utilizes controlled electric fields to create these scars, offering a safer alternative to traditional thermal energy methods.

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Seamus Larroque

CDPO / CPIM / ISO 27005 Certified


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iliomad is deligthed to have supported the ICM - Institut du Cancer de Montpellier in their CNIL's authorization process

We are delighted to share that the ICM - Institut du Cancer de Montpellier was authorized by the French Data Protection Authority (CNIL) to conduct APAD-ECO study. The CNIL granted authorization to conduct a medico-economic study on the effects of physical activity in women treated for breast cancer on April, 19th. This groundbreaking study involves combining data from two clinical trials with that of the Caisse nationale de l’Assurance Maladie, covering the period from 2009 to 2022. The study aims to assess the long-term impacts of physical activity in patients who have undergone treatment for breast cancer. We are proud to have contributed to this project by providing the ICM - Institut du Cancer de Montpellier with a compliant Data Protection Impact Assessment (DPIA), a crucial step in obtaining CNIL approval.