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Oct 16, 2024

FDA grants marketing authorisation for CMR's Versius system

Versius helps surgeons control endoscopic instruments during cholecystectomy for adult patients aged 22 years and older. The US Food and Drug Administration (FDA) has granted marketing authorisation

Versius helps surgeons control endoscopic instruments during cholecystectomy for adult patients aged 22 years and older.

The US Food and Drug Administration (FDA) has granted marketing authorisation for the Versius surgical system, developed by CMR Surgical.

This authorisation allows for the introduction of a next-generation surgical robot in the US.

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Versius is a multi-port, soft tissue, general surgical, robotic-assisted surgical device (RASD). It is the first to gain FDA authorisation through the De Novo application process.

It is designed to assist surgeons in controlling endoscopic instruments with precision during cholecystectomy procedures in adult patients aged 22 years and older.

The system’s compact and modular design allows for easy integration into operating rooms, enhancing versatility and portability.

Versius mimics the human arm, providing surgeons with dexterity and accuracy through small, fully wristed instruments. It also features 3D HD vision, intuitive instrument control and ergonomic working positions, potentially reducing surgeon stress and fatigue.

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As a digitally driven system, it has continuous software innovation, ensuring that users benefit from the latest technological advancements.

In preparation for US market entry, CMR Surgical will implement its global metrics-based training programme, which includes advanced tools such as the Versius Trainer, eLearning platforms and virtual reality components to facilitate the transition from training to operating room practice.

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.”

The system has already achieved significant global adoption, securing a CE Mark in 2019 and becoming the second most utilised surgical robotic system worldwide, with more than 26,000 procedures completed across seven specialities.

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