FDA updates in urology: April 2025

Welcome to Urology Times’® monthly FDA update! Last month, key developments included the clearance of a wireless, catheter-free urodynamics system for lower urinary tract dysfunction (LUTD) and a submission for an expanded indication of nogapendekin alfa inbakicept-pmln (NAI, Anktiva) for papillary non–muscle invasive bladder cancer (NMIBC).

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Key updates include clearance of a catheter-free urodynamics system and submission for an expanded indication of a bladder cancer agent.

FDA news in urology for April 2025

1. FDA grants 510(k) clearance to Glean Urodynamics System

On April 2, 2025, Bright Uro announced FDA 510(k) clearance for the Glean Urodynamics System for the evaluation of LUTD in adults.¹ The device enables wireless, catheter-free ambulatory urodynamics monitoring that can provide improved patient comfort and more physiologically accurate data compared with previous options, the company reported.

2. FDA clears stapler for use with da Vinci SP surgical system

On April 10, 2025, Intuitive Surgical announced FDA 510(k) clearance for the SureForm 45 stapler for use with the da Vinci SP surgical system in urologic, thoracic, and colorectal procedures.² The stapler is designed for use in conjunction with Intuitive’s single-port surgical system, da Vinci SP, which is cleared in the US for urologic, transoral otolaryngology, colorectal, and thoracic procedures.

3. FDA approval sought for Anktiva in papillary NMIBC

On April 15, 2025, ImmunityBio announced submission of a supplemental biologics license application (sBLA) to the FDA seeking expanded approval of NAI with BCG for BCG-unresponsive NMIBC cancer in the papillary indication.³ The sBLA is supported by data from cohort B of the ongoing QUILT-3.032 trial (NCT03022825), which showed a 24-month disease-free survival rate of 48.3% and a 7% cystectomy rate. Anktiva was previously approved in April 2024 for use in combination with BCG for patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary disease.

4. FDA clears AI-powered application for measuring prostate volume

On April 25, 2025, Clarius Mobile Health announced FDA clearance for Clarius Prostate AI, an application that measures prostate volume during handheld ultrasound exams.⁴ The tool is activated using a smartphone or tablet, where it then highlights the prostate and places calipers that can be manually adjusted. This application adds to Clarius’ product portfolio, which includes Bladder AI for measuring bladder volume.

REFERENCES

1. Bright Uro receives FDA clearance for Glean Urodynamics System. News release. Bright Uro. April 2, 2025. Accessed May 1, 2025. https://www.businesswire.com/news/home/20250402777960/en/Bright-Uro-Receives-FDA-Clearance-for-Glean-Urodynamics-System

2. U.S. FDA clears first stapler designed for single-port robotic surgery. News release. Intuitive Surgical. April 10, 2025. Accessed May 1, 2025. https://isrg.intuitive.com/news-releases/news-release-details/us-fda-clears-first-stapler-designed-single-port-robotic-surgery

3. ImmunityBio announces FDA submissions of supplemental BLA for NMIBC papillary disease and for expanded access of ANKTIVA to treat lymphopenia. News release. ImmunityBio. April 15, 2025. Accessed May 1, 2025. https://immunitybio.com/immunitybio-announces-fda-submissions-of-supplemental-bla-for-nmibc-papillary-disease-and-for-expanded-access-of-anktiva-to-treat-lymphopenia/

4. FDA clears new Clarius Prostate AI to help physicians assess and diagnose common urologic conditions in minutes. News release. Clarius Mobile Health. April 25, 2025. Accessed May 1, 2025. https://www.prnewswire.com/news-releases/fda-clears-new-clarius-prostate-ai-to-help-physicians-assess-and-diagnose-common-urologic-conditions-in-minutes-302437687.html