Virtuoso Surgical has secured de novo authorisation from the US Food and Drug Administration (FDA) for its endoscopic robot for the intact removal (en bloc) of bladder tumours.
The Tennessee-based company’s Virtuoso Endoscopy System, which secured breakthrough device designation from the FDA in September 2025, is authorised for en bloc resection of bladder lesions in adult patients to obtain tissue samples, including bladder muscle, in order to aid in the diagnosis and treatment of bladder cancer.