Virtuoso Robotic System Earns FDA De Novo Nod for En Bloc Bladder Resection

The FDA has granted De Novo authorization to the Virtuoso Endoscopy System for en bloc resection of bladder lesions in adult patients to obtain tissue samples, including detrusor muscle, to aid in the diagnosis of bladder cancer, according to a news release from Virtuoso Surgical.¹ The authorization establishes a new device classification for electromechanical surgical systems used in endoluminal procedures, and the system is intended for use by trained surgeons in an operating room. Supporting data came from the VIABLE study (NCT06940648), and the company plans a focused US launch at urology centers in 2027.

What did early VIABLE data show with the Virtuoso system?

Among the first 20 patients treated in the VIABLE study at The Chinese University of Hong Kong, detrusor muscle was present in 94% of resected lesions, exceeding the study's prespecified goal of 60% and the approximately 70% median reported for conventional transurethral resection of bladder tumor (TURBT). Surgical margins could be assessed in 93% of malignant lesions, and no intraoperative adverse events (AEs) were reported. The company stated that these findings are preliminary, come from a single site with a limited number of patients, and may not predict outcomes in larger populations or in commercial use.

Principal investigator Jeremy Yuen-Chun Teoh, MBBS, FRCSEd, FCSHK, FHKAM, of The Chinese University of Hong Kong, said surgeons with varying levels of en bloc experience were able to obtain high-quality specimens with the system.¹

What were the results from the first phase of VIABLE?

Results from the first-in-human phase 1 portion of the study, published in European Urology Oncology, included 6 patients with 12 lesions; the median age was 76 years (IQR, 65-85), and 67% of patients were male.² All 12 lesions (100%) were excised en bloc or with a modified en bloc technique, and no patients required conversion to standard equipment. The mean procedural time was 52 ± 20 minutes, and the mean tumor size was 13 ± 9.3 mm.

Detrusor muscle was present in all specimens (n = 12/12), and evaluable margins were present in 91% of urothelial tumors (n = 10/11). No intraoperative AEs, bladder perforations, 30-day reoperations, or 30-day deaths occurred. Two patients (33%) experienced postoperative AEs: 1 had grade 1 urinary retention that resolved with conservative management, and 1 developed a chest infection related to a newly diagnosed esophageal tumor with tracheal invasion. The median duration of catheterization and the median hospital stay were each 1 day (IQR, 1-1.8), and the 30-day readmission rate was 33%.

How is the VIABLE trial designed?

VIABLE is a single-center, nonrandomized study evaluating the safety and effectiveness of the system for bladder lesion excision at Prince of Wales Hospital, The Chinese University of Hong Kong, with an estimated enrollment of 30 patients.³ Outcome measures include the rate of en bloc or modified en bloc excision, complications graded by the Clavien-Dindo classification, significant bladder perforation requiring intervention, urethral injury, and 30-day mortality. Patients with bladder dome or diverticular lesions, a tumor base greater than 3 cm, prior pelvic radiation, or transurethral resection within the past 6 months were excluded.

How does the Virtuoso Endoscopy System work?

The system places 2 needle-sized, superelastic nitinol robotic arms at the tip of a rigid endoscope, which surgeons control from a console. One arm lifts and retracts tissue while the other dissects, enabling 2-handed manipulation through the urethra. The platform uses concentric tube technology developed at Vanderbilt University, Johns Hopkins University, and Vanderbilt University Medical Center, and it received breakthrough device designation from the FDA in September 2025.

References

1. Virtuoso Surgical receives FDA De Novo authorization for its robotic system for en bloc resection of bladder lesions. News release. Virtuoso Surgical. November 10, 2026. Accessed November 10, 2026. https://tinyurl.com/ycxndhye
2. Teoh JY, Bracco FM, Wong JH, Liu AQ, Yuen VW, Lai FP. A novel transurethral robotic platform for performing en bloc resection of bladder tumour: results from the first phase of the VIABLE trial. Eur Urol Oncol. 2026;9(1):111-115. doi:10.1016/j.euo.2025.11.005
3. Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) trial. ClinicalTrials.gov. Updated June 24, 2026. Accessed November 10, 2026. https://tinyurl.com/mpj5sa5f