Versius Surgical Robot (CMR Surgical)
Modular robotic-assisted surgical system with individually mobile arms, deployed in Europe, Australia, and Asia markets pending U.S. FDA clearance.
What This Technology Is
Versius is a robotic-assisted surgical system developed by CMR Surgical, a UK-based company. The system uses a modular design with individual, mobile robotic arms rather than a single integrated unit.
Key features:
- Modular arms: Small, individually mobile robotic units that can be positioned around the patient as needed
- Portable design: Arms are smaller and more maneuverable than competing systems
- Open surgeon console: The surgeon has visibility of the patient and OR team
- Wristed instruments: Articulating instrument tips for enhanced dexterity
Versius is designed for laparoscopic procedures across multiple surgical specialties.
Where It Is Deployed
Versius has received CE Mark certification and is deployed in hospitals across Europe, Australia, and Asia. As of 2024, it has not received FDA clearance for the U.S. market, limiting its deployment to countries where regulatory approval has been obtained.
Applications include:
- Gynecologic surgery
- Colorectal surgery
- Upper GI surgery
- Thoracic surgery
CMR Surgical has emphasized the system's smaller footprint and flexibility compared to larger robotic platforms, positioning it for hospitals with space constraints or those seeking more cost-effective robotic options.
Known and Documented Failure Modes
Given Versius's deployment outside the U.S., adverse event documentation in FDA databases is not available. Documented and potential failure categories:
Modular architecture considerations
- Arm-to-arm coordination with separate mobile units
- Arm positioning and stability
- Communication between independent units and console
General robotic surgery risks
- Instrument malfunction
- Calibration errors
- Software failures
- Electrical or thermal injury
Learning curve
- Surgeon adaptation to different console design
- Institutional experience with setup and troubleshooting
Oversight and Regulatory Context
Versius has CE Mark certification under EU MDR. The system is not FDA-cleared, so U.S. patients do not have access.
International regulatory pathways vary, and approval in one jurisdiction does not guarantee approval or timing in others. Patients in different countries may have different access to surgical robotic options.
Why This Matters
The growth of surgical robotics outside the established U.S. market leader creates options for hospitals and patients internationally. Modular designs like Versius may offer advantages in flexibility and cost structure.
For patients, relevant questions remain consistent:
- What is the outcome track record at their institution?
- Does their surgeon have adequate experience with this platform?
- What happens if the system malfunctions?
External Resources
- CMR Surgical — Versius — Manufacturer information (commercial source)
Related Coverage
Report an Incident
If you have direct knowledge of a Versius system malfunction, unexpected outcome, or safety concern at any facility worldwide, you can submit documentation to Safety Ledger.