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- Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devicesJapan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…
- Philips issues updated use instructions for Lumify ultrasound systems after software glitch riskPhilips Ultrasound has sent a letter to customers of its Lumify diagnostic ultrasound system, advising that the devices require updated use instructions. The update addresses a software applicatio…