Regulatory & Reimbursement
Market Pathways Scorecard: FDA Breakthrough Devices
A graphic review of FDA Breakthrough Device program activity and NTAP coverage.
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FDA Output
FDA Output, November 2024
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in November 2024. Updated November 19.
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Regulatory & Reimbursement
EU Activity, Health Commissioner Holdup, and Global Picks
In this week’s Pathways Picks: The latest EU notified body survey results show an acceleration in MDR activity and a slight deceleration in IVDR applications and certifications; a new guidance on European vigilance is published with more attention to diagnostics; approval of the EU health commissioner nominee is in doubt; and updates from the UK, Singapore, Malaysia, China, and ISO.