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 30.
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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: First FDA LLM Clearance?
Did FDA clear a product that incorporates a large language model? Excerpted from Pathways’ Picks July 1: FDA Clears an LLM? Asia Updates, Ireland’s Elevation, and More.