Virtuoso Surgical has secured de novo authorisation from the US Food and Drug Administration (FDA) for its endoscopic robot for the intact removal (en bloc) of bladder tumours.
The Tennessee-based company’s Virtuoso Endoscopy System, which secured breakthrough device designation from the FDA in September 2025, is authorised for en bloc resection of bladder lesions in adult patients to obtain tissue samples, including bladder muscle, in order to aid in the diagnosis and treatment of bladder cancer.
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According to Virtuoso, FDA de novo authorisation for the system makes it the first device in a new FDA classification of electromechanical surgical systems for endoluminal surgical procedures. Virtuoso plans a focused US launch at leading urology centres in 2027.
The use of Virtuoso’s system involves the placement of two needle-sized robotic arms at the tip of a rigid endoscope, with these robotic arms following a surgeon’s hand motions from a console. One of the arms is intended to be used in lifting and retracting tumour tissue, while the other dissects beneath it, bringing two-handed dexterity to endoscopic surgery through the urethra, the company stated.
In the first 20 patients involved in the Virtuoso-sponsored VIABLE study (NCT06940648), all treated at The Chinese University of Hong Kong, detrusor muscle was present in 94% of removed lesions, exceeding the study’s 60% performance goal and the median rate of approximately 70% reported across published studies of conventional transurethral resection of bladder tumour therapy (TURBT). Pathologists use the detrusor muscle to see the stage of cancer.
Virtuoso’s CEO, Duke Herrell, commented: “This is a major milestone for our team and for patients with bladder cancer.
“Removing a tumour intact can provide a better tissue specimen, which supports clearer diagnosis and staging. We are excited to give surgeons a new tool for this common, recurrent, and potentially deadly cancer.”
There were over 600,000 cases of bladder cancer worldwide in 2022, as per figures from the World Cancer Research Fund. TURBT has been the historical standard of care for bladder cancer, typically followed by the administration of immunotherapy. While most bladder cancers are caught early, research indicates that they have a high tendency to recur and necessitate lifelong checkups.
GlobalData analysis reveals that the global robotic surgery market is growing at a CAGR of 6.3% and is forecast to reach a valuation of $23.6bn in 2035, up from $12.8bn in 2025.
