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 25.
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The Brief
Argá Medtech Update: Swiss PFA Start-Up Prepares for Commercialization
Argá Medtech expects to join the increasingly competitive pulsed field ablation market by 2028 with its Coherent Sine-Burst Electroporation system.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: Bundled Payments for Joint Replacements
CMS advances novel payment models in orthopedics. Excerpted from Pathways’ Picks April 15: New Medicare Directions, AI Picks, and Global Regulatory Updates