French-American surgical equipment manufacturer Moon Surgical has received the US Food and Drug Administration (FDA) approval for the commercial version of its Maestro surgical system.
Maestro is designed to support surgeons, operating room staff and patients in soft tissue surgical procedures that are not currently supported by available telerobotic systems.
It is a small and adaptable surgical system that can be integrated into the existing clinical workflows over any laparoscopic indication.
The system comes with NVIDIA Holoscan, a powerful edge computing platform that allows the deployment of real-time AI-based algorithms in the operating room during surgery.
Its capabilities would enhance operating room efficiency, allowing alternative labour models to provide shorter and more predictable procedure duration.
Moon Surgical CEO and MD Start partner Anne Osdoit said: “Our Maestro System introduces a new category of robotic surgery tailored for the broad laparoscopy market, enabling robotics utilisation on an unprecedented scale.
“We enable healthcare providers to enhance existing tools and optimize surgical services with data-driven insights.
“This clearance is very timely and will bolster the remarkable traction we’ve had following the recent SAGES conference, with US sites eagerly lining up to join our Limited Market Release.”
In December 2022, Moon Surgical received the first FDA approval and completed the first-in-human studies using its Maestro surgical robotics system.
The company completed 30 surgical procedures in seven clinical indications, including bariatric interventions, hernia repairs, colorectal surgeries, and gastric reflux surgery.
The Maestro surgical system secured CE mark approval in September last year, and it was used for treating more than 200 patients at two pilot sites in Europe.
The company will now deploy its Maestro system in the US and Europe in a Limited Market Release, with plans for a broader launch in 2025.
Moon Surgical board chair Fred Moll said: “The team at Moon Surgical has been impressively delivering on schedule while adding resources to get ready for its commercial phase.
“After a fantastic initial experience in Europe in a real-world, multi-speciality setting, we are eager to implement Maestro programs at select US sites over the next few months.”
