Virtuoso Endoscopy System (Virtuoso Robotic System): FDA status

Approved Approved Nov 10, 2026. Indication: En bloc resection of bladder lesions including detrusor muscle for diagnostic evaluation of bladder cancer. Company: Virtuoso Surgical.

Regulatory history

• Nov 10, 2026: De Novo authorization. FDA granted De Novo authorization to the Virtuoso Endoscopy System, a transurethral robotic platform for en bloc resection of bladder lesions in adults, creating a new device classification. Urology Times / Virtuoso Surgical press release

All products in the FDA Tracker