CMR Surgical’s Versius robotic system has received FDA clearance, paving the way for advanced minimal access surgery in the United States.
At a Glance
- Versius, a multi-port, soft tissue general robotic-assisted surgical device, has received de novo approval from the FDA.
- The system is designed for adult patients eligible for soft tissue minimal access surgery, specifically for cholecystectomy.
- Versius features collaborative arms, bedside units, and customizable port placement for patient-specific needs.
- The platform has completed over 26,000 surgical procedures since receiving CE mark in 2019.
- CMR Surgical plans to introduce Versius to the U.S. market, expanding access to robotic-assisted surgery.
Revolutionizing Surgical Procedures
CMR Surgical has achieved a significant milestone with the FDA’s de novo clearance for its Versius surgical robotic system. This groundbreaking development allows the innovative platform to enter the U.S. market, potentially transforming the landscape of minimal access surgery. Versius has been cleared for adult patients undergoing cholecystectomy, or gallbladder removal.
The Versius system has collaborative arms that mimic human movements, bedside units for enhanced control, and customizable port placement to accommodate individual patient needs. These attributes aim to reduce surgeon fatigue and improve communication within the surgical team.
CMR Surgical obtained a de novo clearance from the FDA for its Versius surgical system, allowing its modular laparoscopic robot to enter U.S. shores. https://t.co/FhbXMrpxrZ
— Fierce Medtech (@FierceMedTech) October 14, 2024
Proven Track Record and Future Prospects
Since receiving its CE mark in 2019, the Versius platform has demonstrated its efficacy and reliability by completing over 26,000 surgical procedures worldwide. This impressive track record spans multiple continents, including Latin America, Brazil, the Middle East, Africa, and Asia, showcasing the system’s versatility and global appeal.
“The U.S. is an important strategic market so gaining FDA authorization for Versius for use in cholecystectomy procedures in adult patients is a significant step forward in CMR achieving its mission of bringing minimal access surgery to more patients around the world,” Massimiliano Colella, Interim Chief Executive Officer at CMR Surgical, said.
As CMR Surgical prepares to introduce Versius to the U.S. market, the company is implementing a comprehensive global metrics-based training program. This initiative includes virtual reality and eLearning tools, ensuring that surgeons and medical staff are well-equipped to utilize the advanced technology effectively.
Expanding Access to Advanced Surgical Care
The introduction of Versius to the U.S. market is expected to significantly expand access to robotic-assisted surgery. The system’s compact and modular design allows for easy integration into various operating rooms and care settings, making it accessible to a wider range of healthcare facilities.
The Versius system is supported by a suite of digital applications that provide real-time insights and optimize surgical programs. This integration of advanced technology, including Virtual Reality (VR) tools for training, positions Versius as a cutting-edge solution in the rapidly evolving field of surgical robotics.
As CMR Surgical targets the soft-tissue surgery market, estimated to exceed $7 billion, the company is well-positioned to capitalize on the growing demand for advanced surgical solutions. With recent fundraising efforts, including a $165 million round in September and a $600 million venture capital round in 2021, CMR Surgical has the financial backing to support its expansion plans and continue innovating in the field of robotic-assisted surgery.
Sources
- CMR Surgical lands FDA clearance for Versius robot amid CEO swap
- US FDA clears CMR Surgical’s robotic device to assist gall bladder removal
- FDA clears Versius surgical robot from CMR Surgical