The Apple Watch’s Atrial Fibrillation (AFib) History feature, which records and alerts the wearer’s relevant cardiac events, has been qualified to join the FDA’s Medical Device Development Tools (MDDT) program – a first for a “digital health technology”. This means that the Apple Watch is now usable in clinical studies requiring estimated data on the time the user spent in atrial fibrillation while wearing the device. 9to5Mac reports.
The FDA announcement describes its use as a non-invasive way to collect data before and after treatment:
Designed for use as a biomarker test to help evaluate estimates of atrial fibrillation burden as a secondary efficacy endpoint in clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices to be treated.
Apple has long touted its watch as a lifesaver for those who wear one. Features like fall detection and car crash detection have helped save lives. Apple often cites in its marketing anecdotes from Apple Watch customers who say they visited their doctor after receiving heart alerts on their wrists, potentially saving their lives. However, increased anxiety due to additional data could also be detrimental.
The FDA previously cleared two Apple Watch functions as a direct-to-consumer wearable device with an EKG and to alert you if you have an irregular heartbeat, starting with the Series 4 in 2018. It also clarified that the apps are “not intended to replace traditional methods of diagnosis or treatment” – if you feel unwell or have questions, you should always rely on a real doctor. The Apple Watch does not diagnose conditions, and one study suggests that treatments for these conditions are not suitable for the typical Apple Watch user.
News Source : www.theverge.com
Entertainment