UK-based medical devices company CMR Surgical has received the US Food and Drug Administration (FDA) De Novo marketing authorisation for its Versius Surgical System.
Versius is a portable robotic-assisted surgical device (RASD) intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments.
It is designed to help surgeons perform endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.
The device is indicated for use in adult patients aged 22 years and above, who are eligible for soft tissue minimal access surgery (MAS), for cholecystectomy.
In 2019, the Versius surgical system received CE mark approval in Europe.
CMR claims that Versius is the second most used surgical robotic system worldwide, and is the first multi-port, soft tissue general surgical RASD to receive FDA authorisation.
CMR Surgical chief medical officer and co-founder Mark Slack said: “Securing FDA marketing authorisation 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 authorisation, 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 US.”
Versius is a compact and modular portable surgical robot that can easily integrate into virtually any operating room to perform cholecystectomy procedures.
The device is designed to biomimic the human arm, helping surgeons with optimised port placement, dexterity, and accuracy of small, fully wristed instruments.
It offers 3D HD vision, easy-to-adopt instrument control, and a choice of ergonomic working positions, and can be easily moved between departments.
The device features an open surgeon console to reduce stress and fatigue for the surgical team while facilitating clear communication.
Also, it comes with a suite of digital apps that provide real-time insights to improve proficiency and optimize surgical robotic programmes.
Furthermore, the UK medical devices company intends to launch the Versius system in the US, together with its global metrics-based training programme.
CMR Surgical interim CEO Massimiliano Colella said: “The US is an important strategic market so gaining FDA authorisation 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.
“The value of Versius as a compact and modular system has been demonstrated by leading hospitals around the world, and we look forward to working closely with hospitals in the US to introduce Versius.”
