FDA hands de novo authorization to Virtuoso endoscopic surgical robot

The FDA has granted de novo authorization to Virtuoso Surgical for its miniaturized robotic platform for endoscopic surgery.

The system 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. The agency’s initial green light covers its use in single-piece resections of bladder tissue through the urethra, to help diagnose cancer.

“Removing a tumor intact can provide a better tissue specimen, which supports clearer diagnosis and staging,” Virtuoso CEO Dr. Duke Herrell said in a statement. “We are excited to give surgeons a new tool for this common, recurrent, and potentially deadly cancer.”

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