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Apple Watch approved for AFib studies

Apple Watch
Translate from : Apple Watch godkendt til AFib-studier
Apple Watch approved by FDA for AFib clinical studies. The watch can now be used to monitor irregular heartbeats, which could be a game changer in the fight against heart disease.
By Maria
9 may. 2024 06:10 am
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The Apple Watch has become very versatile since it was first introduced by Apple. It has proven to be a lifesaver in several cases thanks to its impressive portfolio of features. The latest news is that the Apple Watch can now be used in AFib clinical trials, thanks to a new FDA approval.

This is good news for Apple after the issues related to pulse oximetry patent rights that affected the Watch Series 9 and Watch Ultra 2. The United States Food and Drug Administration (FDA) has approved the atrial fibrillation (AFib) detection software on the Apple Watch and this can be used for clinical trials . Apple Watch's AFib history feature is the first digital health technology to be scaled through the FDA's Medical Device Development Tools (MDDT) program.

Atrial fibrillation is an abnormal heartbeat that is also known as arrhythmia. The AFib history feature is designed to observe a subject's AFib burden week estimation before and after using a cardiac ablation device during a clinical trial.

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The Apple Watch AFib History feature regularly checks the user's heart rate for signs of AFib. After a week of monitoring, it estimates how often your heart beat irregularly while wearing the Apple Watch. The AFib detection software is also designed to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary efficacy endpoint in clinical trials to evaluate the safety and efficacy of cardiac ablation devices.

These are important new devices that can significantly reduce the burden of atrial fibrillation on a patient. It is noted that atrial fibrillation can be detected by several traditional methods, including the use of an EKG or even a home blood pressure monitor. There are also some smart wearable devices besides the Apple Watch that are capable of detecting atrial fibrillation.

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