MetaMedical™ Solutions Inc

FDA grants clearance for commercial version of Moon Surgical’s Maestro robot

Moon Surgical has received clearance from the US Food and Drug Administration (FDA) for the commercial version of its Maestro surgical system.

The company previously received FDA clearance for a non-commercial version of the system in September 2022. In September 2023, Maestro was used to assist in weight loss surgery procedures in the US.

In addition to its surgical assistance capabilities, Maestro is equipped with the edge computing platform NVIDIA Holoscan, which enables real-time algorithms based on AI to be deployed in the operating room for immediate benefits during surgery.

Since obtaining the CE mark in September 2023, Maestro has been used to treat more than 200 patients to date in general, bariatric, and gynaecologic surgery at two European pilot sites.

With the second clearance from the FDA, the system will now be deployed in additional select US and European cities ahead of a broader launch next year.

“Our Maestro System introduces a new category of robotic surgery tailored for the broad laparoscopy market, enabling robotics utilisation on an unprecedented scale,” said Moon Surgical CEO Anne Osdoit.

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Moon Surgical board chair Fred Moll added: “After a fantastic initial experience in Europe in a real-world, multi-speciality setting, we are eager to implement Maestro programmes at select US sites over the next few months.”

In May 2023, Moon Surgical raised $55.4m in venture funding in a Series B funding round co-led by Sofinnova Partners, through its Sofinnova Capital Strategy, and NVIDIA’s venture capital arm, NVentures.

The funds add to a $31.4m Series A raise that concluded in June 2022.

UK-based robotics company CMR Surgical also scooped  $165m to continue development of its surgical robot named Versius.

GlobalData forecasts that the overall robotics industry is growing at a CAGR of 17% and will be worth $217.6bn by 2030. The robotic surgery systems market value stood at around $2.8bn in 2023 and is set to be worth around $6.6bn by 2030.

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