CMR Surgical obtained a de novo clearance from the FDA for its Versius surgical system, finally allowing its modular, cart-based, laparoscopic robot to come to U.S. shores.
Versius previously received a CE Mark approval in Europe in early 2019. The Cambridge, U.K.-based company said the multi-port system was cleared by the agency for gallbladder removal procedures, in patients ages 22 and up who are eligible for minimally invasive surgery.
The green light comes on the heels of last week’s news that CEO Supratim Bose would be stepping down from the position for personal reasons and that he planned to return to Singapore after about a year and a half with the company. CMR’s chief commercial officer, Massimiliano Colella, was named interim CEO.
Colella joined the company in December 2023, after serving as CEO at Evercare Group and as president of Europe, Middle East and Africa operations at Smith & Nephew.
“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," Colella said in a statement. Alongside the stateside rollout, CMR will also offer its metrics-based surgeon training program, comprising of the Versius Trainer and the Versius eLearning platforms as well as peer-to-peer connectivity and virtual reality apps.
CMR also made changes to its senior leadership team just last month, bringing on Michelle Paknad as a senior VP for global business development, as the company gears up its international commercial efforts.
Also a Smith & Nephew alum, Paknad had helped lead its robotics franchise as VP of global robotics and digital health, and previously held sales and marketing positions at Intuitive Surgical. In addition, CMR welcomed Markus Bauman as chief legal and business affairs officer, after working as general counsel at the cloud software developer Matillion.
While awaiting an FDA clearance, following its submission late last year, CMR has placed Versius systems in Latin America and Brazil, as well as the Middle East, Africa and Asia, and the company said its hardware has completed more than 26,000 keyhole procedures to date.
Previously, CMR said that about 90% of its customers were employing the compact, movable system within multiple hospital departments, while about 25% had deployed Versius across as many as seven surgical specialties.
Last September, the former Fierce 15 winner raised $165 million U.S. to bolster its geographic expansions—after collecting a monster $600 million venture capital round in mid-2021—as it chases a soft-tissue surgery market that it has estimated to be north of $7 billion and growing.
Editor's note: This story has been updated to include additional information and statements released by the company.