Pathways’ Pick of the Week
Pathways' Pick of the Week: Modernizing Inspections
FDA lays out a new vision for inspections. Excerpted from Pathways Picks August 5: Medicare Tightens NTAP Access, MDUFA Money, UK on AI Scribes, and More.
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Regulatory & Reimbursement
Pathways' Pick of the Week: FDA Floats GenAI Plan
FDA proposes a “competency” framework for regulating generative AI; Excerpted from Pathways Picks August 19: FDA GenAI Plan, Commish Nom, Global Picks, and More.
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ICYMI
The End of Watchful Waiting for AAAs
New device-based interventions for AAA may offer an alternative to prolonged surveillance in treating abdominal aortic aneurysms. Excerpted from our recent MTS feature, "Living Under Surveillance: Can New AAA Treatments Change the Story?"
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Regulatory & Reimbursement
Pathways Pick of the Week: UK Eyes Centralized Licensing
UK floats legislation that could lead to direct MHRA device reviews. Excerpted from Pathways Picks September 2: UK Eyes Centralized Licensing, FDA-SEC Pact, and More.