Summary: CMR Surgical’s Versius Surgical System has received FDA marketing authorization, making it the first multi-port soft tissue Robotic Assisted Surgical Device (RASD) to be authorized through the FDA’s De Novo process. Versius is designed to assist in minimally invasive soft tissue surgeries, with its compact, versatile, and surgeon-friendly features.
Key Takeaways:
- Versius is the first multi-port soft tissue RASD approved through the FDA’s De Novo process, expanding robotic-assisted surgery options.
- The system is designed to enhance surgeon comfort and patient care through its biomimetic design and advanced control features.
CMR Surgical announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the Versius Surgical System (Versius). This paves the way for the next-generation, versatile, adaptable, and digitally driven surgical robot to be introduced in the United States.
First RASD to be Authorized Through FDA’s De Novo Process
The FDA marketing authorization of Versius marks a significant milestone for CMR, as Versius is the first multi-port, soft tissue general surgical Robotic Assisted Surgical Device (RASD) to be successfully authorized through the FDA’s De Novo application process.
Versius is designed to assist in the precise and accurate control of Versius Surgical endoscopic instruments. It is indicated in the U.S. for adult patients, 22 years or older, eligible for soft tissue minimal access surgery, specifically for cholecystectomy procedures. The system is compact, modular, and portable, making it adaptable to virtually any operating room.
Enhanced Surgeon Experience and Patient Care
Versius biomimics the human arm, providing optimized port placement, and offers dexterity and accuracy with small, fully wristed instruments. The system features 3D HD vision, intuitive control, and ergonomic working positions, all aimed at reducing surgeon stress and fatigue while enhancing communication with the surgical team.
“Securing FDA marketing authorization for Versius for use in cholecystectomy in adult patients is a significant milestone for CMR and, most importantly, for hospitals and patients who will now have greater access to robotic-assisted surgery in cholecystectomy procedures,” said Mark Slack, chief medical officer and co-founder at CMR Surgical.