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The EU issues a hotly anticipated guide on the “interplay” between the new AI Act and established device and diagnostic regulations. Excerpted from Pathways’ Picks June 25: Aligning the AI Act and MDR, EU Inches Toward MDSAP, Tarver Talks to Makary.
FDA will hold a meeting in early August to discuss recommendations for a renewed user fee program. Excerpted from Pathways’ Picks June 11: MDUFA Meeting, Companion Dx 510(k)s, Next-Gen Sequencing in China, and More.
The UK plans funding guarantees for medtech. Excerpted from Pathways’ Picks July 2: CMS Prior Authorization, FDA Cybersecurity Guide, and UK Funding Guarantees.
FDA will hold a meeting in early August to discuss recommendations for a renewed user fee program. Excerpted from Pathways’ Picks June 11: MDUFA Meeting, Companion Dx 510(k)s, Next-Gen Sequencing in China, and More.