This marks the first time a "digital health technology" has been included in the program, according to 9to5Mac.

The inclusion of the Apple Watch in the MDDT program means that it can now be used in clinical studies that require estimated data on the amount of time wearers spend in atrial fibrillation while using the device. This noninvasive method of collecting data can prove invaluable in evaluating the effectiveness of cardiac ablation devices used in the treatment of AFib.

Apple has long promoted the life-saving potential of its smartwatch, with features like fall detection and car crash detection credited with saving lives. Users have shared anecdotes of visiting their doctors after receiving heart-related alerts on their wrists, potentially leading to timely medical interventions that could have saved their lives.

However, the additional data provided by the Apple Watch may also lead to added anxiety for users. It is important to note that the FDA has clarified that the Apple Watch should not replace traditional methods of diagnosis or treatment. If users experience any unusual symptoms or have concerns, they should consult a healthcare professional for proper evaluation and guidance.

The FDA had previously granted clearance to two functions of the Apple Watch: the ability to perform electrocardiograms (starting with the Series 4 in 2018) and to notify users of irregular heartbeats. These functions also came with the stipulation that they should not be considered as replacements for professional medical advice.

While the Apple Watch does not diagnose conditions, its inclusion in the MDDT program and the subsequent use of its AFib history feature in clinical studies highlight the potential of wearable devices in contributing to medical research and treatment advancements. However, it is crucial for users to rely on medical professionals for accurate diagnosis and personalized treatment plans, as not all treatments for cardiac conditions may be suitable for typical Apple Watch users, as suggested by a recent study.

Overall, the qualification of the Apple Watch's AFib history feature for the FDA's MDDT program marks an important milestone in the recognition of digital health technologies in clinical research. With proper utilization and guidance, wearable devices like the Apple Watch hold the potential to make significant contributions to the healthcare field.