FDA Output
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 11.
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Outside Opinion
From Rules to Results: What a Decade of Medical Device Outcomes Taught Us About Screening
In medical devices, the path to market is often shorter and more visible than in therapeutics, but that does not make investing straightforward. The challenge shifts earlier from science to commercialization, reimbursement, and buyer fit, and survival is far more common than meaningful liquidity. Can disciplined screening improve angel outcomes? Alex Pederson and Yaniv Sneor, Mid Atlantic Bio Angels.
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Regulatory & Reimbursement
Pathway's Pick of the Week: Europe’s Breakthroughs
The EU has launched its pilot breakthrough program. Excerpted from Pathways’ Picks May 8: Notified Body Rules, EU Breakthroughs, China Exemptions, and More.