Generative AI in Medical Devices: Explore 7 key questions shaping FDA regulatory expectations in 2026, from AI model validation and patient safety to human oversight and continuous monitoring. Key takeaways In August 2026, the FDA published a discussion paper on regulating generative AI medical devices and asked the industry for feedback. The paper is not guidance. It does not set new requirements, but it shows how the FDA is thinking. Seven themes run through it: risk, users

7 essential cybersecurity decisions to make during the medical device design stage to improve patient safety, data protection and regulatory readiness. Key takeaways Medical device cybersecurity is a patient safety issue, not only an IT or data issue. Architecture, components and update methods are hard to change after development, so security has to be decided during design. Seven early decisions set how secure a connected device will be across its whole life. Regulators, e