9:18

Dec 31, 2025

12/31/25 - Radiology AI 510(k) Exemption Petition, Oncology Approval Conversions and CAR-T Expansion, AI Drug Development Tool Q

This episode examines the FDA’s formal public comment period on a citizen petition requesting conditional 510(k) exemption for radiology AI devices, comparing U.S. finding-by-finding clearance requirements against international multi-finding approval pathways. Coverage includes December oncology regulatory activity, featuring traditional approval conversions for pirtobrutinib and rucaparib, first-in-indication CAR-T approval for marginal zone lymphoma, and breakthrough therapy designations for HER2-targeted therapies. The briefing also covers the FDA’s first qualification of an AI-based drug development tool for MASH trials, CapsoVision’s PMA submission for AI-powered capsule endoscopy, and the progression of imaging systems into multimodal clinical integration platforms supporting precision medicine workflows.

11:16

Dec 30, 2025

12/30/25 - PathAI Dual Regulatory Qualification, FDA-CMS TEMPO Pilot, AI Diagnostic Clearances Across Pathology and Imaging

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.

9:04

Dec 29, 2025

12/29/25 - AI Imaging Transition to Operational Standard, FDA Expanded Access and Device Clearance Updates, Remote Monitoring In

This episode examines the operational transition of AI-powered diagnostic imaging from pilot deployments to clinical standard across U.S. health systems in 2025, including the workflow integration challenges, workforce development requirements, and change management investments that determined deployment success. The briefing covers FDA’s October 2025 expanded access guidance revisions clarifying physician-sponsor roles and IRB waiver procedures, alongside new premarket notification exemptions for radiology computer-aided detection devices. The episode also analyzes the infrastructure maturation that enabled remote patient monitoring to reach critical mass through actionable dashboards, alert fatigue reduction, and hybrid staffing models, while addressing the elevation of healthcare cybersecurity to board-level strategic priority following attacks on connected medical devices and operational technology.

8:38

Dec 28, 2025

12/28/2025 - FDA AI Device Change Control Guidance, RSNA Imaging Platform Integration, Pediatric Migraine and Alzheimer Approval

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.

12:56

Dec 27, 2025

12/27/25 - FDA Exempts Radiology CAD Devices, Multi-Stage AI Boosts Breast Cancer Detection, Dragon Copilot Enters athenaOne

This episode examines the FDA’s final rule exempting certain radiology computer-aided detection devices from premarket notification, four new RapidAI clearances for neurovascular triage, and a twenty one percent improvement in breast cancer detection using multi-stage AI applied to digital breast tomosynthesis. Additional coverage includes FDA authorization for Pristina Recon DL’s deep learning-based mammography reconstruction, coronary plaque quantification software from Circle Cardiovascular Imaging, and athenahealth’s planned integration of Microsoft Dragon Copilot into ambient clinical documentation workflows. The briefing also addresses IQVIA’s agentic AI deployment on AWS infrastructure, Zimmer Biomet’s acquisition of Monogram Technologies’ robotic knee replacement platform, and Angle Health’s one hundred thirty four million dollar Series B round for employer benefits automation.

7:56

Dec 26, 2025

12/26/25 - SP 103 Fast Track Lidocaine Patch Development, Abbott TriValve Percutaneous Repair Clearance, FDA Food Traceability R

This episode examines Scilex’s Fast Track designated SP 103 lidocaine patch targeting the ten billion dollar acute low back pain market, Abbott’s TriValve catheter based system cleared for dual valve regurgitation repair without open heart surgery, and FDA’s thirty month delay of Food Traceability Final Rule compliance from January 2026 to July 2028. The briefing covers rolling submission requirements for expedited drug development timelines, minimally invasive valve repair platform expansion, and traceability infrastructure readiness across higher risk food supply chains under Food Safety Modernization Act mandates.