FDA updates in urology: September 2025

Welcome to Urology Times’® monthly FDA update! This month’s notable regulatory decisions span the gamut of urologic care—including new approvals in bladder cancer, solid tumors, and benign conditions.

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FDA News in Urology for September 2025

1. FDA approves gemcitabine intravesical system for BCG-unresponsive NMIBC

On September 9, 2025, Johnson & Johnson announced that the FDA had approved their gemcitabine intravesical system (Inlexzo; formerly TAR-200) for adult patients with BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. This approval is based on results from cohort 2 of the phase 2b SunRISe-1 trial, which demonstrated a complete response rate of 82%, with 51% of patients maintaining a complete response for at least 1 year.

2. FDA approves Altaviva device for urge urinary incontinence

On September 19, 2025, Medtronic announced FDA approval of the Altaviva implantable tibial neuromodulation device for adult patients with urge urinary incontinence. The approval was supported by results from the pivotal TITAN 2 trial, which enrolled participants across 29 clinical trial sites in the US.

3. FDA approves pembrolizumab for subcutaneous injection for solid tumors

On September 19, 2025, Merck announced FDA approval of pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection across previously approved solid tumor indications for intravenous pembrolizumab in patients 12 years and older. This approval is based on results from the phase 3 MK-3475A-D77 trial, which demonstrated noninferior pharmacokinetics, efficacy, and safety compared with the intravenous formulation, while reducing treatment time and health care resource use.

4. FDA grants clearance to BioTraceIO360 for kidney ablation

On September 22, 2025, Techsomed announced FDA 510(k) clearance of its BioTraceIO360 software platform for use in percutaneous kidney ablation. This clearance expands on the system’s prior liver ablation indication, supporting a unified multi-organ image-guided therapy platform.

5. FDA grants breakthrough device designation to Virtuoso Surgical Robotic System

On September 23, 2025, Virtuoso Surgical announced FDA Breakthrough Device designation for its Virtuoso Surgical Robotic System for en bloc excision of bladder lesions. This designation is based on the system’s potential to enhance surgical precision and enable broader adoption of en bloc resection techniques, which have been shown to reduce cancer recurrence and improve pathological staging compared with standard TURBT.