CMR Surgical has secured US Food and Drug Administration (FDA) clearance for its Versius Plus minimally invasive robotic surgical system, priming the company to go ahead with US commercialisation plans in 2026.

Indicated for gallbladder removal procedures, Versius Plus has a modular design, allowing it to be easily moved between hospital departments and integrated into existing surgical workflows.

Versius Plus’s FDA clearance follows the agency’s de novo classification of CMR’s first-generation Versius robot in October 2024.

CMR Surgical president and US general manager Chris O’Hara commented: “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.

“FDA clearance represents an exciting opportunity to partner with healthcare systems across the US. Versius Plus is designed to support a broad range of soft-tissue procedures, and we are diligently advancing additional indications in the US and aim to help make robotic-assisted surgery more accessible than ever before.”

The global robotic surgical systems market is growing at a compound annual growth rate (CAGR) of 12.1% and is projected to reach a valuation of $9.2bn by 2034, up from $2.9bn in 2024, according to a GlobalData market model.

In April, CMR secured a $200m equity and debt investment to help expedite Versius’ US commercialisation. Versius Plus is already available in the UK and Europe.

The company’s Versius clearance follows the FDA’s clearance of Microbot’s LIBERTY, a single-use, remotely operated robotic system for peripheral endovascular procedures in September.

Outside of the US, CMR’s robotic surgical platforms are claimed to have completed over 40,000 surgical procedures. First launched in 2000, Intuitive Surgical’s da Vinci surgical robot dominates the robotic surgery sector in the US by a wide margin, with a US market share of 86.5%, according to a GlobalData market model.