FDA Output
FDA Output, June 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in June 2026. Updated June 15.
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Investors & Dealmaking
MedTech Capital Matters May 2026
We present selected private financings for May, a month in that saw several $50 million-plus rounds for medical device companies.
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Pathways’ Pick of the Week
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.