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The FDA has granted de novo authorization to Virtuoso Surgical, a Nashville-based company, for its miniaturized robotic platform for endoscopic surgery. The initial authorization covers single-piece resection of bladder lesions through the urethra, to help diagnose cancer. The system had received breakthrough designation from the FDA last year.
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Virtuoso delivers two needle-sized instruments through the tip of a rigid endoscope, which can independently grasp and cut tissue through a single port less than a centimeter wide. Concentric nitinol tubes, controlled from a surgeon console, let the instruments bend and extend.
In a previous 20-patient clinical study, the company retrieved the deeper muscle layer of the bladder wall in 94% of lesions removed in one piece, which pathologists need to judge how far a tumor has spread. Virtuoso compares that with a historical median of about 70% in conventional transurethral resections, though the comparison is not from a head-to-head trial. Surgical margins could be evaluated in 93% of removed lesions.
CEO Dr. Duke Herrell said removing a tumor intact “can provide a better tissue specimen.” The company plans a limited launch in urology centers next year and has studied the robot preclinically in lung, gynecology and neurosurgery.
For the broader MedTech space, the authorization adds a new entrant to endoscopic robotics, a category distinct from the large soft-tissue platforms.
