Virtuoso Endoscopy System Receives FDA De Novo Authorization: The First Device in a New Classification for Endoluminal Surgical Systems, Authorized for En Bloc Resection of Bladder Lesions in Adults
Nashville, Tennessee — Virtuoso Surgical announced on November 10 that the U.S. Food and Drug Administration has granted De Novo authorization for the Virtuoso Endoscopy System. It is the first device in a new FDA classification, electromechanical surgical systems for endoluminal surgical procedures, and is authorized for en bloc resection of bladder lesions in adult patients to obtain tissue samples, including detrusor muscle, to assist in the diagnostic evaluation of bladder cancer. The system previously received FDA Breakthrough Device Designation in September 2025.
The company says the system places two needle-sized robotic arms at the tip of a rigid endoscope. Made of superelastic concentric nitinol tubes, the arms follow the surgeon's hand motions from a console, with one arm lifting and retracting tissue and the tumor while the other dissects beneath it.
In the first 20 patients of the company-sponsored VIABLE study, all treated at The Chinese University of Hong Kong, detrusor muscle was present in 94 percent of removed lesions, above the study 60 percent performance goal and the median rate of approximately 70 percent reported across published studies of conventional transurethral resection. Surgical margins could be evaluated in 93 percent of malignant lesions, and there were no intraoperative adverse events. The company notes the results are preliminary and from a single site.
For background, the American Cancer Society estimates about 84,530 Americans will be newly diagnosed with bladder cancer in 2026. The company plans a focused U.S. launch at leading urology centers in 2027, and says uses in gynecology, pulmonary procedures and neurosurgery remain investigational and are not FDA-authorized. This report covers the authorization and study facts only and offers no individual treatment advice.
Source: Business Wire
Published by GSM · USA (original Chinese edition)
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