FDA Output
FDA Output, February 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in February 2026. Updated February 9.
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Business Strategies
Valuing Data in a Complex Healthcare Ecosystem
An expert panel convened by MTS and Weill Cornell Medicine examined how hospitals, digital health innovators, medtech companies and investors are defining and benchmarking data value in real-world transactions and recommended frameworks for strengthening data-sharing agreements.
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Regulatory & Reimbursement
Pathways' Pick of the Week: EU Unveils MDR and IVDR Overhaul
Across-the-board streamlining is proposed. Excerpted from Pathways’ Picks December 17: EU Overhaul, FDA Real-World Evidence Shift, and More Updates in End-of-Year Global Policy Bonanza.