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FDA recalls faulty iOS app that injured hundreds of insulin pump users


The US Food and Drug Administration has issued a Class 1 recall for an iOS app that interfaces with an insulin pump due to a software glitch...

While criticisms regarding the agency's slow processes are common, recent efforts indicate a commitment to enhance oversight of healthcare tech. This feature, which detects signs of sleep apnea using a Samsung Galaxy Watch and phone, was the first of its kind to be authorized by the FDA, following previous approval by Korea's Ministry of Food and Drug Safety last October. However, the FDA has been struggling to keep pace with ongoing rollouts, largely due to a lack of strategic emphasis and limited resources.

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FDA Recalls Defective iOS App That Injured Over 200 Insulin Pump Users