First Takes
Medicare Tests AI-Based Prior Authorization for Devices
CMS will launch a model in January to test AI-enabled prior authorization review for 15 devices and procedures to reduce "wasteful care" under fee-for-service Medicare.
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Regulatory & Reimbursement
FDA Output, June 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in June 2025. Updated June 30.
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Pathways' Document Depot
Pathways Document Depot: Cataloging Medtech Policy
A sortable and searchable running inventory of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.