CMR Surgical’s Versius robotic system receives FDA clearance, marking a significant advancement in minimally invasive surgical technology for U.S. healthcare institutions.
At a Glance
- FDA grants de novo clearance for CMR Surgical’s Versius system, allowing entry into the U.S. market
- Versius is cleared for gallbladder removal procedures in patients 22 and older
- The system is compact, modular, and portable, integrating into various operating rooms
- Versius has already completed over 26,000 procedures globally
- CMR Surgical aims to expand its presence in the $7 billion soft-tissue surgery market
Revolutionary Robotic System Enters U.S. Market
CMR Surgical has achieved a major milestone with the FDA’s de novo clearance of its Versius surgical system. This breakthrough allows the company to introduce its advanced robotic-assisted surgical technology to the United States healthcare market. The Versius system is now authorized for use in gallbladder removal procedures for patients aged 22 and above who are eligible for minimally invasive surgery.
As the first multi-port, soft tissue general surgical Robotic Assisted Surgical Device (RASD) authorized through the FDA’s De Novo process, Versius represents a significant advancement in surgical technology. Its compact, modular, and portable design allows for seamless integration into various operating rooms and care settings, potentially increasing access to minimally invasive procedures for patients across the country.
US FDA clears CMR Surgical's robotic device to assist gall bladder removal https://t.co/WIboioTrnV pic.twitter.com/bseDbnMzTF
— Reuters (@Reuters) October 15, 2024
Innovative Features for Enhanced Surgical Precision
The Versius system boasts several innovative features that set it apart in the field of robotic-assisted surgery. Its design biomimics the human arm, offering optimized port placement, dexterity, and accuracy with small, fully wristed instruments. This design aims to enhance surgical precision and potentially improve patient outcomes.
“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. With FDA authorization, we can now bring our compact and portable surgical robot to the world’s largest healthcare market, expanding the benefits of robotic-assisted surgery with Versius across various care settings in the U.S.” – Mark Slack, Chief Medical Officer and Co-founder at CMR Surgical
Surgeons using Versius benefit from 3D HD vision, ergonomic working positions, and an open console design. These features are intended to reduce stress on the surgical team and improve communication during procedures. The system is also digitally driven, offering continuous software updates and digital apps that provide real-time insights to surgical teams.
Global Success and Future Expansion
Prior to its FDA clearance, Versius had already established a strong global presence. The system secured CE Mark approval in 2019 and has become the second most utilized surgical robotic system worldwide. With over 26,000 procedures completed across Latin America, Brazil, the Middle East, Africa, and Asia, Versius has demonstrated its versatility and effectiveness in various healthcare settings.
“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
CMR Surgical’s entry into the U.S. market is part of a comprehensive strategy to expand its global footprint. The company recently raised $165 million for geographic expansion, following a $600 million venture capital round in 2021. With the U.S. soft-tissue surgery market estimated to exceed $7 billion, CMR Surgical is well-positioned to capitalize on this significant opportunity.
Training and Implementation Strategy
To ensure the successful adoption of Versius in U.S. hospitals, CMR Surgical plans to implement a comprehensive metrics-based training program. This program will include virtual reality and eLearning platforms, providing surgeons and surgical teams with the necessary skills and knowledge to effectively utilize the Versius system.
“I have enjoyed being part of the development of Versius since 2017 and it is very exciting that hospitals across the U.S. can benefit from this next-generation technology. The U.S. is a mature market for surgical robots, so it is hard to believe that until today there was little choice when deciding to start a soft tissue robotics program. Versius securing FDA clearance is an important step forward for helping hospitals of any size to be able to offer robotic-assisted surgery.” – Erik Wilson, M.D., Division Director and Vice Chair of Surgery at University of Texas McGovern Medical School at Houston
As CMR Surgical begins its U.S. rollout, the company will partner with select hospitals to introduce Versius and expand its presence in the market. This strategic approach aims to ensure a smooth integration of the technology into existing surgical practices and maximize its potential benefits for patients and healthcare providers alike.
Sources:
- US FDA clears CMR Surgical’s robotic device to assist gall bladder removal
- CMR Surgical lands FDA clearance for Versius robot amid CEO swap
- CMR Surgical Receives U.S. FDA Marketing Authorization for Versius Surgical System
