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 29.
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Start-Ups to Watch
Urologic Health: Noninvasive Bladder Function Testing Removes Diagnostic Barriers in Urology
Today’s catheter-based system for urodynamic testing is often uncomfortable and painful, such that it’s almost a last resort, even though it’s the only tool clinicians have for accurately diagnosing and treating the causes of lower urinary tract symptoms. Urologic Health aims to burst that bottleneck with a new, noninvasive modality for urodynamic testing.
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Regulatory & Reimbursement
Pathways' Pick of the Week: Shuren Joins MedTech Innovator
The former CDRH Director is joining the MedTech Innovator accelerator as an advisor. Excerpted from Pathways’ Picks June 24: Devices Selected for EU Tech Assessments, Breakthrough Pilot, and More Medtech Policy Picks.