Regulatory recap: FDA approvals in urology from Q1 of 2026

The first quarter of 2026 brought a wave of regulatory activity across the urology landscape, with 8 distinct FDA actions recorded between January and March. These regulatory approvals and clearances spanned both benign and oncologic indications, reflecting continued momentum in both device innovation and pharmacologic development across the field.

Notable themes emerging from Q1 include a strong emphasis on minimally invasive and non-invasive solutions, with multiple device clearances prioritizing anesthesia-free or outpatient-friendly approaches. SonoMotion's Break Wave lithotripsy system and Prodeon Medical's Urocross Expander System exemplify this trend in stone disease and benign prostatic hyperplasia (BPH), respectively, whereas Elidah's Elitone for Men brings at-home neuromuscular therapy to men recovering from prostate surgery.

On the pharmacologic front, IBSA USA's VYBRIQUE introduced a novel oral film formulation of sildenafil for erectile dysfunction, and Ferring Pharmaceuticals received approval for a streamlined thawing protocol for its bladder cancer gene therapy, nadofaragene firadenovec-vncg (Adstiladrin), aimed at improving clinical workflow.

Together, these advances signal a quarter defined by both refinements to existing therapies and meaningful new options for patients across the urologic spectrum. Take a look through last quarter’s key regulatory decisions in the recap below, and stay up to date on the latest from Urology Times® by subscribing to our newsletters!

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January

FDA grants 510(k) clearance to Break Wave lithotripsy device for kidney stones

Date: January 21, 2026

Company: SonoMotion

Summary: On January 21, 2026, SonoMotion announced FDA 510(k) clearance for the Break Wave lithotripsy device for the treatment of patients with kidney stones.¹ The approval was supported by data from the pivotal SOUND trial, which demonstrated the safety and efficacy of the noninvasive, anesthesia-free ultrasound system in patients with upper urinary tract stones. Break Wave can be used in conjunction with SonoMotion’s previously cleared Stone Clear device to fragment stones and facilitate post-procedural fragment clearance.

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February

FDA approves sildenafil oral film for men with erectile dysfunction

Date: February 5, 2026

Company: IBSA USA

Summary: On February 5, 2026, IBSA USA announced FDA approval of VYBRIQUE, a sildenafil oral film for the treatment of erectile dysfunction in men aged 18 and older.² This approval is based on results from a 12-week, phase 3 randomized trial (NCT05490680) in 475 adult men, in which the sildenafil oral film demonstrated statistically significant improvements in sexual function vs placebo. VYBRIQUE is a single-dose, orally dissolving film that can be taken with or without water. The film, which is designed for discreet administration, is expected to be commercially available in the US in March 2026.

FDA approves label changes for first batch of menopausal hormone therapy products

Date: February 12, 2026

Company: N/A

Summary: On February 12, 2026, the FDA approved labeling changes removing boxed warning language regarding cardiovascular disease, breast cancer, and probable dementia for select menopausal hormone replacement therapies (HRT).³ This approval is based on a comprehensive review of the scientific literature, including randomized data demonstrating reduced all-cause mortality and fractures among women who initiate hormone therapy within 10 years of menopause onset. The action represents the first batch of revisions following the agency’s November 2025 decision to align HRT labeling with the current evidence.

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March

FDA approves Pylarify TruVu formulation of PSMA-PET agent piflufolastat F18

Date: March 6, 2026

Company: Lantheus

Summary: On March 6, 2026, Lantheus announced FDA approval of Pylarify TruVu (piflufolastat F 18) injection, a new formulation of its PSMA-PET imaging agent for use in prostate cancer.⁴ Piflufolastat F 18 injection was initially approved in the US in May 2021 based on data from the phase 2/3 OSPREY (NCT02981368) and phase 3 CONDOR (NCT03739684) trials. The updated formulation is designed to improve product stability at higher radioactive concentrations, enabling more efficient manufacturing, broader distribution, and expanded patient access. Commercial availability of Pylarify TruVu is expected in Q4 of 2026.

FDA grants 510(k) clearance to Urocross Expander System for BPH-related LUTS

Date: March 16, 2026

Company: Prodeon Medical

Summary: On March 16, 2026, Prodeon Medical announced FDA 510(k) clearance for the Urocross Expander System for the management of lower urinary tract symptoms secondary to BPH.⁵ The approval was based on data from the Expander-1 feasibility trial and Expander-2 pivotal trial. In Expander-2, the System demonstrated a 74.5% responder rate at 12 months and no device-related serious adverse events, with preservation of sexual function. The non-permanent implant is designed for temporary placement and retrieval, offering a minimally invasive option that maintains future treatment flexibility.

FDA approves accelerated thawing method for nadofaragene in NMIBC

Date: March 24, 2026

Company: Ferring Pharmaceuticals

Summary: On March 24, 2026, Ferring Pharmaceuticals announced FDA approval of a label update for nadofaragene firadenovec-vncg (Adstiladrin) to introduce an accelerated thawing protocol for patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ.⁶ This approval is based on a thawing and handling study demonstrating maintained product integrity with thawing in a 25 °C (77 °F) water bath over approximately 25 minutes. The updated protocol is expected to streamline intravesical preparation and improve clinical workflow efficiency without altering storage conditions post-thaw.

FDA grants clearance to Asurys Fluid Management System for endoscopic urologic procedures

Date: March 30, 2026

Company: Boston Scientific

Summary: On March 30, 2026, Boston Scientific announced FDA 510(k) clearance for the Asurys Fluid Management System to provide irrigation and distention during endoscopic urologic procedures, including ureteroscopy.⁷ The system is designed to automatically adjust irrigation flow based on real-time intrarenal pressure (IRP) readings obtained from the LithoVue Elite Single-Use Digital Flexible Ureteroscope with IRP monitoring. In addition to ureteroscopy, the system is also designed to be a single irrigation management system for cystoscopy, percutaneous nephrolithotomy, and BPH procedures.

FDA clears neuromuscular stimulation device for post-prostatectomy incontinence

Date: March 31, 2026

Company: Elidah

Summary: On March 31, 2026, Elidah announced FDA 510(k) clearance for Elitone for Men, a non-invasive neuromuscular stimulation device for the treatment of urinary incontinence following prostate surgery.⁸ This approval is based on clinical data demonstrating accelerated continence recovery, as well as a 92% reduction in 24-hour pad weight at 12 weeks compared with 68% in controls. The at-home device delivers daily pelvic floor stimulation to improve muscle strength and bladder control, with anticipated over-the-counter availability in April 2026.

REFERENCES

1. SonoMotion announces FDA clearance for its Break Wave lithotripsy device for treatment of kidney stones. News release. SonoMotion, Inc. January 21, 2026. Accessed March 31, 2026. https://www.prnewswire.com/news-releases/sonomotion-announces-fda-clearance-for-its-break-wave-lithotripsy-device-for-treatment-of-kidney-stones-302666229.html

2. IBSA USA announces FDA approval of VYBRIQUE™, the first and only oral film to treat men with erectile dysfunction. News release. IBSA USA. February 5, 2026. Accessed March 31, 2026. https://www.businesswire.com/news/home/20260205186522/en/IBSA-USA-Announces-FDA-Approval-of-VYBRIQUE-the-First-and-Only-Oral-Film-to-Treat-Men-with-Erectile-Dysfunction

3. FDA approves labeling changes to menopausal hormone therapy products. News release. FDA. February 12, 2026. Accessed March 31, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products

4. Lantheus announces FDA approval of Pylarify TruVu (piflufolastat F 18) injection. News release. Lantheus Holdings, Inc. March 6, 2026. Accessed March 31, 2026. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-approval-pylarify-truvutm-piflufolastat-f

5. Prodeon Medical receives FDA 510(k) clearance for the Urocross® Expander System, a novel non-permanent retrievable implant for treating urinary symptoms associated with benign prostatic hyperplasia. News release. Prodeon Medical. March 31, 2026. Accessed March 16, 2026. https://www.globenewswire.com/news-release/2026/03/16/3256258/0/en/Prodeon-Medical-Receives-FDA-510-k-Clearance-for-the-Urocross-Expander-System-a-Novel-Non-Permanent-Retrievable-Implant-for-Treating-Urinary-Symptoms-Associated-with-Benign-Prostat.html

6. U.S. FDA approves label update to accelerate thaw time for ADSTILADRIN® (nadofaragene firadenovec-vncg). News release. Ferring Pharmaceuticals. March 24, 2026. Accessed March 31, 2026. https://www.businesswire.com/news/home/20260324850788/en/U.S.-FDA-Approves-Label-Update-to-Accelerate-Thaw-Time-for-ADSTILADRIN-nadofaragene-firadenovec-vncg

7. Boston Scientific receives FDA clearance for the Asurys™ Fluid Management System. News release. Boston Scientific Corporation. March 30, 2026. Accessed March 31, 2026. https://www.multivu.com/boston-scientific/9282251-en-boston-scientific-fda-clearance-asurys-fluid-management-system

8. New FDA-cleared at-home treatment helps men regain bladder control after prostate surgery. News release. Elidah. March 31, 2026. Accessed March 31, 2026. https://elitone.com/wp-content/uploads/2026/03/Elitone-for-Men-Press-Release-033126.pdf