This episode examines the FDA’s year end updates to AI and machine learning medical device guidance, establishing change control protocols and post market surveillance requirements for adaptive algorithms. We cover platform level AI integration strategies from Siemens, GE, and Philips at RSNA 2025, including photon counting CT and enterprise orchestration dashboards. The briefing also reviews cloud infrastructure expansions from Google, Microsoft, and NVIDIA supporting clinical reasoning models and edge processing, alongside August regulatory approvals for fremanezumab in pediatric episodic migraine, the lecanemab autoinjector for at home Alzheimer treatment, and exemptions for certain radiology computer aided detection devices from premarket notification.
