FDA updates in urology: May 2026

Welcome to Urology Times’® monthly FDA update! This month’s regulatory activity includes 2 notable approvals in the bladder cancer space—circulating tumor DNA (ctDNA)-guided atezolizumab (Tecentriq) as adjuvant therapy for muscle-invasive bladder cancer (MIBC) and durvalumab for BCG-naïve, high-risk non–muscle invasive bladder cancer (NMIBC). The month of May also welcomed FDA submissions for the Edison Histotripsy System for the destruction of kidney tumors and for nogapendekin alfa inbakicept-pmln (Anktiva) in papillary NMIBC.

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FDA news in urology from April 2026

1. FDA clears Glean Abdominal Sensor, expanding catheter-free urodynamics platform

On May 7, 2026, the FDA granted 510(k) clearance to the Glean Abdominal Sensor, expanding the Glean Urodynamics System to enable multi-channel urodynamic testing in a wireless, catheter-free ambulatory format.¹ According to Bright Uro, the clearance broadens the system’s capability to capture abdominal and detrusor pressure alongside cystometry and pressure flow measurements without catheter interference.

2. FDA grants de novo authorization to Aurie Reusable Intermittent Catheter System

On May 11, 2026, the FDA granted de novo marketing authorization to the Aurie Reusable No-Touch Intermittent Catheter System.² According to the company, the system is expected to launch within Veterans Health Administration spinal cord injury hospitals later in 2026.

3. Edison Histotripsy System submitted to FDA for kidney tumor indication

On May 11, 2026, HistoSonics announced that they had submitted a de novo request to the FDA seeking authorization to expand the indication for its Edison Histotripsy System to include destruction of renal tumors.³ The submission is supported by data from the prospective, multicenter, single-arm pivotal #HOPE4KIDNEY study (NCT05820087), which is evaluating the use of focused ultrasound–based histotripsy in patients with primary solid renal tumors.

4. FDA grants clearance to total testosterone assay

On May 13, 2026, the FDA granted clearance to Revvity’s automated chemiluminescence immunoassay (ChLIA) for total testosterone measurement.⁴ The assay is designed to support diagnostic testing for androgen-related disorders, including suspected hypogonadism. The clearance adds to Revvity’s previously cleared ChLIA assays for free testosterone and sex hormone-binding globulin (SHBG), allowing laboratories to perform multiple testosterone-related measurements on a single platform.

5. FDA approves atezolizumab as adjuvant therapy for MIBC guided by ctDNA

On May 15, 2026, the FDA approved atezolizumab and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as adjuvant treatment for adult patients with MIBC who have ctDNA molecular residual disease, as determined by an FDA-authorized test.⁵ The agency simultaneously approved the Signatera CDx as a companion diagnostic to identify patients with ctDNA MRD who are eligible for treatment.

The approval is backed by data from the phase 3 IMvigor011 trial (NCT04660344), in which atezolizumab demonstrated a statistically significant improvement in investigator-assessed disease-free survival (stratified HR, 0.64; 95% CI, 0.47 to 0.87, stratified P = .0047) and overall survival (HR, 0.59; 95% CI, 0.39 to 0.90; P = .0131) compared with placebo among ctDNA-positive patients.

6. FDA to review sBLA for nogapendekin alfa inbakicept for BCG-unresponsive papillary NMIBC

On May 19, 2026, ImmunityBio reported that the FDA had accepted a supplemental biologics license application (sBLA) seeking an expanded approval of nogapendekin alfa inbakicept in combination with BCG for patients with BCG-unresponsive NMIBC with papillary disease without carcinoma in situ.⁶ The agency issued a PDUFA target action date of January 6, 2027.

7. FDA grants breakthrough device designation to Vesta Bladder Risk Stratify Dx

On May 20, 2026, the FDA granted Breakthrough Device Designation to Vesta Bladder Risk Stratify Dx, an artificial intelligence–enabled digital pathology assay intended to prognosticate bladder cancer risk using routine hematoxylin and eosin–stained pathology slides.⁷ According to the company, the platform is designed to identify predictive image-based features that are not readily appreciable by human review alone.

8. FDA approves durvalumab plus BCG for BCG-naïve, high-risk NMIBC

On May 28, 2026, the FDA approved durvalumab (Imfinzi) in combination with BCG for the treatment of adult patients with BCG-naïve, high-risk NMIBC.⁸ The approval was supported by data from the phase 3 POTOMAC trial (NCT03528694), which demonstrated that adding durvalumab to BCG induction and maintenance significantly improved disease-free survival (DFS) vs BCG induction and maintenance alone (HR, 0.68; 95% CI, 0.50 to 0.93; P = .0154). Grade 3 to 4 treatment-related adverse events occurred in 21% of patients in the durvalumab plus BCG induction/maintenance arm and 4% of patients in the BCG induction/maintenance alone arm.⁹

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