News Summary

• Apple Watch health featuresThe FDA has approved the Apple Watch's atrial fibrillation history feature under its stringent Medical Device Development Tools program that specifies what devices health professionals can rely on.
• Now on top of its allowing the sale of the feature, the Food and Drug Administration has also passed the Apple Watch's AFib history feature for its Medical Device Development Tools (MDDT) program.
• "The average difference between the AFib History Feature and the reference device's weekly burden estimate was 0.67% with a 95% confidence interval of (-0.05%, 1.38%)," says the FDA filing.
• "92.9% (260/280) of subjects had paired weekly AFib burden differences within 5%; 95.7% (268/280) of subjects' weekly AFib burden estimates were within +10% of the reference."
• As well as specifically alerting many users to atrial fibrillation, the feature has led patients to be diagnosed with diabetes.William Gallagher has 30 years of experience between the BBC and AppleInsider discussing Apple technology.
• However, because the Apple Watch does not identify atrial flutter or atrial tachycardia, the FDA says it is qualified "only as a secondary endpoint to compare estimates of AFib burden."