FDA updates in urology: August 2026

Welcome to Urology Times’® monthly FDA update! This month’s regulatory news featured new device and drug developments across benign and oncologic urology care, including 2 advances that build on existing therapeutic platforms.

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FDA news in urology from August 2026

1. FDA clears Revi Extend implant for urgency urinary incontinence

On August 5, 2026, the FDA granted 510(k) clearance to Revi Extend, a next-generation implantable tibial neuromodulation device for urgency urinary incontinence (UUI).¹ Revi Extend maintains the same therapeutic platform as the existing Revi System while increasing the implant longevity from 10 years to 15 years.

2. FDA receives NDA submission for UGN-103 in recurrent LG-IR-NMIBC

On August 17, 2026, UroGen announced that it had submitted a new drug application (NDA) to the FDA seeking approval of UGN-103 (mitomycin) for intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.² UGN-103 is a next-generation mitomycin formulation that builds on the clinical and commercial foundation of Zusduri (mitomycin) for intravesical solution, which received FDA approval in June 2025.

3. FDA grants breakthrough therapy, fast track designations to kidney cancer imaging agent

On August 19, 2026, Norroy Bioscience announced that ⁶⁸Ga-NYM096 had received Breakthrough Therapy and Fast Track designations from the FDA.^{3 68}Ga-NYM096 is an investigational carbonic anhydrase IX (CAIX)-targeted radiopharmaceutical imaging agent for PET imaging of clear cell renal cell carcinoma.

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