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 11.
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Start-Ups to Watch
Nephrodite Addresses Dialysis Pain Points With Implantable Solution
A kidney care start-up’s scaled-down dialysis device will offer patients newfound freedom from the tribulations of end-stage renal disease.
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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.