Virtuoso Surgical, the developer of miniaturized robotic tools for endoscopic surgery, said the FDA granted De Novo authorization for the Virtuoso Endoscopy System.
The company said it's the first device in a new FDA classification, electromechanical surgical systems for endoluminal surgical procedures (robotic instruments passed through an endoscope into the body), and is authorized for en bloc resection of bladder lesions in adult patients to obtain tissue samples, including detrusor (bladder) muscle, to assist in the diagnostic evaluation of bladder cancer.
"This is a major milestone for our team and for patients with bladder cancer," said Virtuoso CEO Duke Herrell, M.D., in a statement. "Removing a tumor 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."
The Virtuoso system places two needle-sized robotic arms at the tip of a rigid endoscope. Made of superelastic concentric nitinol tubes, Virtuoso’s patented robotic arms follow the surgeon's hand motions from a console. One arm can be used to lift and retract tissue and the tumor while the other dissects beneath it, bringing two-handed dexterity to endoscopic surgery through the urethra.
