CMR Surgical wins FDA nod for surgical robot Versius

The US Food and Drug Administration (FDA) has granted a de novo marketing clearance to CMR Surgical’s Versius surgical robotic system to perform soft tissue minimal access surgery for cholecystectomy in adults older than 22 years.

The Versius system received CE Mark approval in Europe in 2019, with the UK-based company boasting that the Versius system is the second most utilised surgical robotic system globally, with more than 26,000 surgical cases completed in seven specialities.

CMR Surgical plans to partner with a “select” number of hospitals as part of the company’s strategy to enter the US market.

Robotic surgical systems have grown in popularity in recent years. According to GlobalData analysis, the surgical robotics market was worth approximately $7.2bn in 2033. It is expected to have a strong compound annual growth rate (CAGR) of 15.7%.

The growth of the robotic surgical systems market is driven by an increased focus on value-based healthcare, which focuses on improving surgical outcomes for patients.

Versius is designed to perform robotic minimal access surgery, where an operation is performed through a series of small incisions in the body into which equipment is inserted. The robotic procedure reduces blood loss, post-surgery pain and recovery time.

The system is more compact and offers portability, which distinguishes it from its peers. The stem also comes with 3D HD vision, easy-to-adopt instrument control and a choice of ergonomic working positions, with an open surgeon console that has the potential to reduce stress and fatigue while allowing for clear communication with the surgical team, according to CMR Surgical.

The company also plans to expand the Versius system's use, starting a trial evaluating its use in paediatric surgeries back in August. CMR has also raised considerable funds to develop and commercialise the Versius system. In September 2023, CMR Surgical raised $165m to continue its development.

There have been multiple recent advancements in surgical robotics, such as using 5G for remote robotic surgery. In December 2023, Microbot Medical partnered with Corewell Health to develop telerobotics between remote centres using the Liberty endovascular robotic surgical system. Telerobotics functionality will allow for the surgical procedure to occur without the surgeon's presence at the relevant site.

CMR has also adopted the latest technology for its Versius system. The company has a training pathway that includes Versius Virtual Reality (VR) and Versius Trainer in VR to improve proficiency on the system.

"CMR Surgical wins FDA nod for surgical robot Versius" was originally created and published by Medical Device Network, a GlobalData owned brand.

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