This episode examines PathAI’s achievement as the first AI-powered pathology system to receive FDA Drug Development Tool qualification for MASH clinical trials following European regulatory approval. The briefing covers the FDA’s Technology-Enabled Meaningful Patient Outcomes pilot program, which coordinates enforcement discretion with CMS reimbursement for up to forty chronic care devices. Additional coverage includes CapsoVision’s five ten k submission for AI-assisted capsule endoscopy, WORK Medical’s manufacturing approval for automated blood cell morphology analysis, Neosoma’s brain metastasis detection platform clearance, and RIVANNA Medical’s ultrasound system expansion. The episode provides operational context for manufacturers navigating coordinated regulatory and payment pathways across trial qualification frameworks and real-world evidence collection requirements.
