FDA grants De Novo authorization to Virtuoso Robotic System for bladder tumor resection

The FDA has granted De Novo authorization to the Virtuoso Endoscopy System, a transurethral robotic platform designed to facilitate en bloc resection of bladder lesions in adults.¹

The authorization establishes a new FDA device classification for electromechanical surgical systems used in endoluminal surgical procedures and permits the system's use to obtain bladder tissue specimens, including detrusor muscle, to assist in the diagnostic evaluation of bladder cancer. By allowing surgeons to manipulate tissue with 2 miniature robotic arms during transurethral resection, the system is designed to facilitate removal of tumors in an intact specimen rather than in multiple fragments.

"How well a bladder tumor is removed at the initial operation shapes how accurately we can stage the cancer and plan what comes next for the patient," said Sam S. Chang, MD, MBA, Patricia and Rodes Hart Professor of Urologic Surgery and Chief Surgical Officer of Vanderbilt-Ingram Cancer Center, in a news release from Virtuoso.¹ "Our current surgical instruments have not significantly changed in more than a century. En bloc tumor resection has been studied in randomized trials and is recognized in international guidelines, but it can be extremely technically demanding with today’s instruments, and adoption has been very limited, especially in the US. A robotic system purpose-built for it, now authorized by the FDA, gives surgeons a meaningful new tool."

FDA authorization and device classification

The authorized indication is specifically for urologic surgery in the bladder when a transurethral approach is appropriate. The system is intended for use by trained surgeons in an operating room. The system previously received FDA Breakthrough Device Designation in September 2025, according to the company.

The Virtuoso platform uses 2 needle-sized robotic arms positioned at the tip of a rigid endoscope. The arms are constructed from superelastic concentric nitinol tubes and are controlled through a surgeon-operated console. One arm can lift and retract the tumor while the other performs dissection beneath the lesion. This configuration is intended to provide 2-handed manipulation through the urethra without requiring an external robotic surgical approach.

VIABLE trial findings

Clinical evidence supporting the technology comes from the Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) study (NCT06940648), a prospective investigation evaluating the safety and effectiveness of the system for transurethral bladder lesion excision.

The first phase of the study was published in European Urology Oncology in February 2026.² In this first-in-human evaluation, investigators treated 6 patients with 12 bladder lesions. All 12 lesions were successfully removed using an en bloc or modified en bloc technique, and none required conversion to conventional resection instruments. Detrusor muscle was present in all 12 specimens, and evaluable surgical margins were obtained in 91%. The mean procedural time was 52 ± 20 minutes.

No intraoperative adverse events (AEs) or complications were reported in this initial cohort. Two patients experienced postoperative AEs (33%): 1 case of grade 1 urinary retention that resolved with conservative management and 1 chest infection subsequently attributed to a newly diagnosed esophageal tumor with tracheal invasion. No bladder perforations, 30-day reoperations, or 30-day deaths occurred.

The company also reported results from the first 20 patients enrolled in VIABLE in its FDA authorization announcement.¹ In this larger cohort, detrusor muscle was present in 94% of resected lesions, exceeding the study's prespecified performance goal of 60%. Surgical margins were evaluable in 93% of malignant lesions, and no intraoperative AEs were reported.

"Robotic en bloc resection with Virtuoso changed how we approach these tumors, even for surgeons experienced in the conventional en bloc technique," said principal investigator Jeremy Teoh, MBBS, FRCSEd (Urol), FCSHK, FHKAM (Surgery), in the news release.¹ "Surgeons newer to en bloc techniques also obtained high-quality specimens, which could help bring this approach to patients everywhere."

Next steps

Virtuoso Surgical has announced plans for a focused US launch at leading urology centers in 2027. The company has also described potential applications of its miniature robotic instruments in gynecology, pulmonary procedures, and neurosurgery, although these uses remain investigational and are not included in the FDA-authorized indication.

Editor’s note: Sam S. Chang, MD, MBA, has served as an adviser to Virtuoso Surgical, has received compensation as a consultant, and holds stock options in the company.

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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://www.businesswire.com/news/home/20261110922061/en/Virtuoso-Surgical-Receives-FDA-De-Novo-Authorization-for-Its-Robotic-System-for-En-Bloc-Resection-of-Bladder-Lesions

2. Teoh JYC, Bracco FM, Wong JHF, et al. 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