Moon Surgical Maestro: What It Is, FDA Status, ScoPilot AI

What Is Moon Surgical's Maestro System?

Maestro is a robotic surgical assistance platform built by Moon Surgical, a medical device company headquartered in Paris, France, with a US base in San Carlos, California. Unlike fully telerobotic surgical systems where the surgeon operates from a remote console, Maestro is designed to sit at the bedside and assist a surgeon who remains scrubbed in and performing the procedure directly.

The system is aimed at the large volume of laparoscopic (minimally invasive, soft-tissue) procedures — general, bariatric, and gynecologic surgery — that Moon Surgical says are not currently served by existing telerobotic surgical systems. It is positioned as an adaptable add-on that can integrate into an operating room's existing laparoscopic workflow rather than replace it.

FDA And CE Regulatory Status

Moon Surgical's regulatory record shows a series of separate, incremental clearances rather than a single approval — a normal pattern for surgical robotics platforms that add capability over time. Reporting on the record includes:

• December 2022 — FDA clearance for an initial version of Maestro.
• September 2023 — CE mark for Maestro in the European Union.
• June 2024 — FDA 510(k) clearance for the commercial version of Maestro, described by Moon Surgical and trade press as covering laparoscopic soft-tissue procedures.
• March 2025 — FDA clearance for ScoPilot, described by Moon Surgical as the industry's first AI-enhanced intraoperative capability on a surgical robot, built on NVIDIA Holoscan and aimed at hands-free laparoscope control.
• July 2025 — FDA 510(k) clearance covering Maestro Connectivity (Wi-Fi/5G data exchange with cloud systems), the Maestro Insights analytics platform, and a Predetermined Change Control Plan (PCCP) that lets Moon Surgical update ScoPilot's AI through a pre-agreed FDA framework rather than seeking a new clearance for every software revision.

ScoPilot: The AI-Powered Feature

ScoPilot is Moon Surgical's AI feature layered onto Maestro, and the company describes it as the industry's first AI-enhanced intraoperative capability cleared for a surgical robot. It runs on NVIDIA's Holoscan edge-computing platform and uses computer vision to track the surgeon's instrument movements so the laparoscope (the camera) can reposition automatically, without the surgeon needing to hand off an instrument to a bedside assistant to adjust the view.

The FDA's clearance of a Predetermined Change Control Plan (PCCP) for ScoPilot in July 2025 is a specific regulatory mechanism, not a general AI approval: it lets Moon Surgical roll out pre-specified improvements to ScoPilot's algorithms over time without filing a new 510(k) submission for each change, provided the changes stay inside the scope the FDA agreed to. Exact version numbers and release dates for ScoPilot's ongoing AI updates are Moon Surgical's to publish; check the company's own newsroom for the current build before citing a specific version.

Company, Funding, And Leadership

Moon Surgical was founded in Paris in 2020, initially under the name MastOR, by Professor Brice Gayet, a laparoscopic surgeon. Anne Osdoit serves as Chief Executive Officer and has been the public face of the company through its FDA clearances and funding rounds. The company operates from headquarters in Paris, France, with a US office in San Carlos, California.

Publicly reported funding includes a $31.3 million Series A in May 2022 and a $55.4 million Series B in May 2023 co-led by Sofinnova Partners and NVIDIA's venture arm, NVentures, alongside investors including Johnson & Johnson Innovation. Reported cumulative totals vary by source (roughly $87–95 million depending on which rounds are counted), so treat any single total as an estimate pending Moon Surgical's own disclosure of a specific figure.

How Maestro Differs From Other Surgical Robots

Maestro's core distinction is that it is an assistive, bedside system rather than a telerobotic one: the surgeon operates with instruments in hand at the patient's side, and Maestro supports tasks like instrument holding and (via ScoPilot) camera control, rather than the surgeon controlling robotic arms from a separate console. That places it in a different category from console-based telerobotic systems, which is the more familiar model most readers associate with surgical robots.

For background on the broader category and how different architectures compare, see our surgical robots overview and our review of the da Vinci Surgical System, a telerobotic platform. Maestro also sits within the wider medical robotics landscape covered in our medical robot brands guide and robotics in healthcare hub.