Dive Brief:
- The Food and Drug Administration granted de novo authorization to Virtuoso Surgical’s robotic system for endoscopic surgery to remove bladder tumors, the company said Tuesday.
- In Virtuoso’s procedure, lesions are removed in one piece in an approach called en bloc resection to obtain tissue for diagnosis of bladder cancer. Two miniaturized robotic arms at the tip of a standard-sized endoscope operate through the urethra, without incisions.
- The robot, which received breakthrough device designation in September 2025, is the first device in a new FDA classification for electromechanical surgical systems used in endoluminal procedures, where instruments pass through an endoscope into the body.
Dive Insight:
Conventional bladder tumor resection typically removes tumors in fragments, disrupting the tumor tissue, the Nashville, Tennessee-based surgical robotics company said. The en bloc resection technique enabled by Virtuoso’s technology can remove tumors in one piece or larger segments.
"Removing a tumor intact can provide a better tissue specimen, which supports clearer diagnosis and staging,” Dr. Duke Herrell, urologic surgeon and Virtuoso’s CEO, said in a statement.
The approach is designed to preserve the tissue and information pathologists need to plan treatment.
“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 U.S.,” Dr. Sam Chang, chief surgical officer of Vanderbilt-Ingram Cancer Center, said in Virtuoso’s statement. “A robotic system purpose-built for it, now authorized by the FDA, gives surgeons a meaningful new tool."
Chang, former chair of the American Urological Association's bladder cancer clinical guideline panel, is a paid consultant to Virtuoso.
In the first 20 patients of the VIABLE study at The Chinese University of Hong Kong, detrusor muscle was present in 94% of the removed lesions, the company said. Detrusor muscle is needed to stage the cancer.
The result exceeded the study's 60% performance goal and the median rate of about 70% reported in studies of conventional bladder tumor resection. No intraoperative adverse events were reported.
Virtuoso plans a focused U.S. launch at leading urology centers in 2027. The company is also exploring use of its platform in other surgical specialties that employ rigid endoscopes and has completed early non-human feasibility work in gynecology, pulmonary procedures and neurosurgery.
