Regulatory & Reimbursement
FDA Output, May 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in May 2026. Updated May 19.
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Business Strategies
Crash and Learn: Common Mistakes That Kill Medtech Start-Ups
Medtech veterans Ken Nelson and Daniel O’Mahony describe the common reasons medtech start-ups fail before reaching profitability or a successful exit.
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Regulatory & Reimbursement
Pathways' Pick of the Week: Devices Remain in EU AI Act
The European Union’s AI Act retains device mandates. Excerpted from Pathways’ Picks May 13: Makary Exits FDA, EU AI Act Reforms Disappoint, UK Seeks Input, and More.