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.
The big picture: The recall underscores the FDA’s challenge in keeping pace with innovation in healthcare technology. While criticisms regarding the agency’s slow processes are common, recent efforts indicate a commitment to enhance oversight of healthcare tech. This includes organizational changes within the Office of Strategic Partnerships and Technology Innovation. Yet, the question remains: Can new bureaucratic measures effectively address the FDA’s shortcomings?
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 causing the app to crash and automatically restart. This intermittent malfunction drains the pump’s battery and may lead to premature shutdown.
