Regulatory & Reimbursement
Pathways' Pick of the Week: FDA Performance Holds Steady
FDA releases performance data. Excerpted from Pathways’ Picks June 18: EU Software Guides, UK Postmarket Law, Stats from Notified Bodies and FDA.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: EU addresses AI Act-MDR Interplay
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.
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Regulatory & Reimbursement
Pathways' Pick of the Week: MDUFA VI Reauthorization to Commence
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.
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ICYMI
US Healthcare Spending by Condition
A comprehensive analysis of US spending on healthcare by condition aims to provide a more accurate assessment of US spending per disease, with potential to inform policy, industry, insurers, and other stakeholders. Excerpted from our recent MTS feature, Type 2 Diabetes, Dental, MSK Top US Healthcare Spending.