Moon Surgical gets FDA approval for mission launch of surgery robot
Moon Surgical has received approval from the U.S. Food and Drug Administration (FDA) to launch its futuristic laparoscopy robot. The Maestro system aids operating room staff during soft tissue surgeries by holding instruments and cameras with two maneuverable robotic arms.
The system is the first of its kind for laparoscopic surgeries and can integrate into existing systems. Moon Surgical said it will now deploy a limited release for Maestro, with full mission rollout set to happen later this year and extend into 2025.
The robot has onboard NVIDIA AI to support surgeons with real-time data on an active procedure. It’s been successfully used to treat more than 200 patients during general, bariatric and gynecologic surgeries at two pilot sites in Europe.
“Our Maestro System introduces a new category of robotic surgery tailored for the broad laparoscopy market, enabling robotics utilization on an unprecedented scale. [The robot allows] healthcare providers to enhance existing tools and optimize surgical services with data-driven insights," Anne Osdoit, CEO of Moon Surgical, said in a statement.
The robot has received a CE mark and has been available in Europe since September 2023.
The expansion into the U.S. surgery market opens the door for it to be used in 18.8 million procedures, the company said. Moon Surgical has headquarters in San Francisco and Paris.
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