02/03/26 - FDA Regulatory Boundary Shifts for LLM CDS, Foundation Model Multi-Indication Clearances, Helium-Free MRI Infrastruct

This episode examines the FDA’s updated guidance on large language model based clinical decision support and a proposed streamlined pathway for radiology AI vendors, Aidoc’s fourteen indication clearance on the CARE foundation model platform, HeartLung’s opportunistic screening clearance, and Google’s release of MedGemma one point five with expanded multimodal imaging capabilities. It also covers GE HealthCare’s Allia Moveo interventional imaging system, Siemens Healthineers’ helium free one point five tesla MRI, Medtronic’s expanded insulin delivery integration with Abbott’s Instinct sensor for Medicare beneficiaries, and recent platform partnerships and funding developments across radiology and point of care ultrasound infrastructure.