After claiming its first U.S. robotic surgery clearance late last year, CMR Surgical is back with a new green light for the upgraded version of its multi-port, laparoscopic platform.
The FDA issued a 510(k) to the company’s Versius Plus system, starting it off with minimally invasive gallbladder removal procedures. The agency previously handed a de novo clearance to the first-generation Versius in October 2024, covering the same cholecystectomy indication.
Compared to its predecessor, Versius Plus incorporates near-infrared fluorescence imaging, dubbed vLimeLite, which highlights blood flow through tissue via the use of glowing indocyanine green dye. The new system can also be equipped with an ultrasonic dissector, representing CMR’s first advanced-energy instrument, and connects with the company’s digital data platform.
Designed to be compact and modular, the cart-based robot aims to allow hospitals to switch between robotic and non-robotic procedures quickly within the same operating space. The system is slated for a 2026 commercial launch.
“Versius Plus is designed to meet the practical realities of today’s healthcare environment—adaptable to different settings, efficient to integrate, and scalable for long-term growth,” Chris O’Hara, CMR’s president and general manager for the U.S., said in a statement.
“FDA clearance represents an exciting opportunity to partner with healthcare systems across the U.S.,” O’Hara added. “Versius Plus is designed to support a broad range of soft-tissue procedures, and we are diligently advancing additional indications in the U.S. and aim to help make robotic-assisted surgery more accessible than ever before.”
Outside of the U.S., the U.K.-based former Fierce Medtech Fierce 15 honoree said its equipment has already completed more than 40,000 procedures across Europe, Asia, the Middle East, Africa and Latin America.
“Built on years of global clinical use data, Versius Plus delivers the flexibility and intelligence today’s healthcare institutions need to advance robotic-assisted surgery,” said CEO Massimiliano Colella, who officially took the helm at CMR in January after serving as chief commercial officer.
The company raised $200 million this past April to bolster its U.S. commercial plans. The proceeds included a combination of equity and debt, with new backing from Trinity Capital, alongside returning investors SoftBank, Ally Bridge Group and Tencent, among others.