FDA grants breakthrough device designation to Virtuoso Surgical Robotic System

The FDA has granted breakthrough device designation to the Virtuoso Surgical Robotic System for bladder lesion removal via en bloc excision, Virtuoso Surgical announced in a news release.¹ 

Breakthrough device designation is granted to devices that offer more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases or conditions. With this designation, the development pathway for the Virtuoso Robotic System can benefit from more frequent feedback from the FDA as well as expedited review.

“Virtuoso is unlike any surgical robot available today, and our vision is to provide surgeons with unprecedented dexterity and control in rigid endoscopic surgery, which is a distinct set of procedures and approaches that have not yet benefited from robotics,” said Duke Herrell, MD, CEO of Virtuoso Surgical and urologic surgeon at Vanderbilt University Medical Center, Nashville, Tennessee, in the news release.¹ “Virtuoso is starting with the removal of bladder lesions, the first critical step in diagnosing, staging, and determining the management for cancerous lesions.”

En bloc resection may increase the accuracy of cancer staging compared with standard transurethral resection of bladder tumor (TURBT) by preserving the integrity of the pathological specimen. In the news release, Virtuoso cited recent randomized study data showing that manually performed en bloc resection techniques significantly reduced 1-year cancer recurrence rates vs standard TURBT.² However, the company noted that the manual method is associated with a significant learning curve, which limits adoption in clinical practice.

The Virtuoso Surgical Robotic System is designed to overcome some of these challenges. The device is a surgeon-controlled system equipped with needle-sized robotic arms, which are intended to enhance the precision and dexterity of minimally invasive surgery.

"The ability to perform an en bloc resection for bladder cancer with this level of robotic assistance is a game-changer even for an expert in the technique,” said Jeremy Teoh, MBBS, FRCSEd (Urol), FCSHK, FHKAM (Surgery), of the Chinese University of Hong Kong, in the news release.¹ “This robotic approach has the potential to enable the widespread adoption of en bloc techniques, thereby minimizing local recurrence and providing a more definitive pathological specimen, which is crucial for guiding subsequent treatment decisions. We are extremely optimistic about what this technology means for the future of bladder cancer surgery and patient outcomes."

Virtuoso plans to seek FDA regulatory approval of their robotic system and explore the use of the device in urology. The company also noted plans to expand into other surgical specialties such as gynecology, pulmonology, otolaryngology, and neurosurgery.

REFERENCES

1. Virtuoso Surgical Robotic System receives FDA Breakthrough Device Designation. News release. Virtuoso Surgical, Inc. September 23, 2025. Accessed September 23, 2025. https://www.businesswire.com/news/home/20250923432688/en/Virtuoso-Surgical-Robotic-System-Receives-FDA-Breakthrough-Device-Designation

2. Teoh JYC, Cheng CH, Tsang CF, et al. Transurethral en bloc resection versus standard resection of bladder tumour: A randomised, multicentre, phase 3 trial. Eur Urol. 2024;86(2):103-111. doi:10.1016/j.eururo.2024.04.015