FDA qualifies Apple Watch’s AFib history for use in clinical studies
The Verge
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Summary
The FDA has approved the atrial fibrillation (AFib) history feature of the Apple Watch for inclusion in its Medical Device Development Tools program. This marks a significant development as it's the first time a digital health technology is approved for use in clinical studies to measure the duration of AFib episodes. This feature will assist in evaluating the effectiveness of cardiac ablation devices in treating heart rhythm irregularities, facilitating non-invasive data collection before and after treatments. This endorsement by the FDA aligns with Apple's ongoing commitment to health-related technologies, acknowledging the device's potential in preventative healthcare while also recognizing the necessity of traditional medical consultation.
