Virtuoso Surgical today announced that the U.S. Food and Drug Administration (FDA) granted De Novo authorization for the Virtuoso Endoscopy System on Oct. 30, 2026. It is the first device in a new FDA classification: electromechanical surgical systems for endoluminal surgical procedures.
The Virtuoso system places two needle-sized robotic arms at the tip of a rigid endoscope, giving urologists two-handed dexterity for en bloc resection of bladder lesions. Removing a lesion in one piece is designed to provide the tissue sample, including detrusor muscle, that pathologists need for diagnostic evaluation.
The system received FDA Breakthrough Device designation in September 2025. Virtuoso plans a focused U.S. launch at leading urology centers in 2027.
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