Maestro System

by Moon Surgical  · Based in France → — Transforming the operating room with Physical AI
General Surgery Obstetrics & Gynecology Urology
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Not publicly disclosed
Regulatory Status Disclosed

Overview

The Moon Surgical Maestro System is a robotic surgical assistant designed to enhance precision and control during laparoscopic procedures. It features two flexible, co-manipulated arms that aid surgeons by holding and manipulating tissues and instruments, compensating for gravitational force and maintaining specified tool positions. The system is compatible with standard laparoscopic cameras and instruments, allowing for seamless integration into existing surgical workflows.

Maestro incorporates advanced AI capabilities, notably the ScoPilot™ feature, which provides intelligent laparoscope control using computer vision-based algorithms. This allows surgeons to maintain a stable and ideal view without needing to remove their hands from other surgical instruments, enhancing efficiency and autonomy.

Beyond the robotic arms, the Maestro System includes the cloud-based Maestro Insights platform. This platform leverages 5G and Wi-Fi connectivity to gather and process intra-operative data, delivering actionable insights to surgical teams and hospital administrators. These insights can help track utilization, monitor progress, optimize scheduling, and improve overall operational efficiencies in the operating room.

The system is also designed with an ergonomic focus to minimize surgeon fatigue and features augmented reality integration to overlay critical anatomical information, further enhancing precision and safety.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Two flexible, co-manipulated robotic arms
  • AI-powered ScoPilot for intelligent laparoscope control
  • Maestro Insights cloud-based platform for procedural data
  • Augmented reality integration for enhanced visual guidance
  • Adaptive machine learning to surgeon techniques
  • Ergonomic design to minimize surgeon fatigue
  • Compact and versatile for easy OR integration
  • Compatible with standard laparoscopic instruments
  • 5G and Wi-Fi connectivity for data exchange
  • Streamlined setup with automated guidance

Use Cases

  • General laparoscopic surgery
  • Cholecystectomies (gallbladder removal)
  • Bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy)
  • Hernia repair
  • Gynecologic surgeries (e.g., endometriosis treatment, ovarian cystectomy)
  • Urologic surgeries (e.g., prostatectomy, nephrectomy, cystectomy)

What Physicians Need to Know

Key Capabilities
The Maestro System features two flexible, co-manipulated arms that provide accuracy and control in laparoscopic surgeries, aiding surgeons by holding or manipulating tissues and positioning laparoscopic cameras and instruments. It offers an intuitive interface, customizable options, and an ergonomic design to minimize surgeon fatigue. The system integrates augmented reality for real-time visual guidance and uses machine learning to adapt to surgeon techniques. Its AI-powered ScoPilot enables real-time laparoscope control based on surgeon's instrument movements. The Maestro Insights platform gathers and processes intra-operative data to deliver valuable insights, track utilization, monitor progress, manage scheduling, and optimize workflows.
Clinical Utility
Maestro enhances surgical precision, facilitates quicker recovery times, and lessens postoperative discomfort. It can reduce the need for a surgical assistant, optimizing OR staff distribution and addressing staffing shortages. The system increases operating room efficiency and minimizes turnover time. Surgeons gain more control and confidence, experiencing reduced fatigue. It enables more patients to receive advanced surgical treatments, including bringing cases typically performed in hospitals to outpatient centers. Studies have shown high surgeon satisfaction (92%) and no device-related serious adverse events.
Integration Options
The Maestro System's compact design allows for easy integration into existing workflows and traditional operating room layouts. It is compatible with standard laparoscopic cameras and instruments. The system features an open architecture that complements leading endoscopy and visualization systems. It leverages NVIDIA Holoscan for real-time sensor processing and is expanding its collaboration with NVIDIA to integrate Isaac for Healthcare for advanced AI capabilities. Active Wi-Fi and 5G connectivity enable seamless data exchange with the Maestro Insights cloud platform, which also acts as a digital hub for other connected devices.
Compliance Status
The Maestro System received FDA 510(k) approval on December 6, 2022, deemed substantially equivalent to the ENDEX Endoscopic Positioning System. It also secured CE mark approval in September 2023. In July 2025, Moon Surgical received FDA 510(k) clearance for Maestro connectivity and a Predetermined Change Control Plan (PCCP) for its AI-powered ScoPilot.
Pricing Model
The Maestro System is designed to be more affordable than other robotic platforms, aiming to democratize access to robotic surgery. Its business model includes all consumables, resources, and software updates in one transparent cost.
User Experience
Surgeons benefit from an intuitive interface, customizable options, and an ergonomic design that reduces fatigue. The system provides stable vision and dependable organ retraction, offering surgeons 'four hands' control while allowing them to use their existing laparoscopic instruments. Minimal training is required for rapid deployment, contributing to a high surgeon satisfaction rate of 92% in studies.
Implementation Complexity
The Maestro System is designed for low implementation complexity due to its compact size and flexibility, allowing easy integration into existing operating room layouts and workflows without extensive changes or setup. It requires minimal staff training and boasts a quick turnover time of five minutes between cases.
Evidence Base
The system has successfully completed a 30-patient first-in-human trial in Belgium, demonstrating safe performance of various laparoscopic surgeries without an assistant. A prospective study on 50 patients for standard laparoscopic digestive surgeries reported 92% surgeon satisfaction and no device-related serious adverse events. Globally, the Maestro System has supported over 1,600 procedures across 60 different types of minimally invasive surgeries. At Lee Health, over 100 procedures using Maestro reported zero adverse events and no increase in operative time or length of stay, with significant savings in surgical tech time.
Physician Tip

The Maestro System offers a significant advantage by providing stable vision and retraction through its co-manipulated arms, effectively acting as an extra pair of hands. This can free up a surgical assistant, allowing for greater surgical focus and efficiency, particularly beneficial in high-volume laparoscopic procedures. Its ease of integration with existing instruments and minimal training requirements make it a highly accessible robotic solution for a broader range of facilities, including ambulatory surgery centers (ASCs). Leveraging the Maestro Insights platform can provide valuable data-driven insights to optimize OR efficiency, scheduling, and refine surgical strategies.

The Maestro System is built for seamless integration into existing surgical environments. It is compatible with standard laparoscopic instruments and visualization systems, ensuring minimal disruption to current workflows. Its open architecture supports connectivity via Wi-Fi and 5G, enabling real-time data exchange with the Maestro Insights cloud platform for analytics and operational optimization. Future advancements are being developed through strategic collaborations with NVIDIA's AI platforms, including Holoscan and Isaac for Healthcare, to further enhance its intelligent capabilities.

Details

Category Practice Analytics & BI, Surgical AI
Pricing Not publicly disclosed
  • Not publicly disclosed; business model includes consumables, resources, and software updates in one cost
DeploymentOn-premise (robotic system) with cloud-based platform (Maestro Insights)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Maestro System (REF100) received 510(k) clearance (K250984) on June 27, 2025, for a software-controlled endoscope and instrument holder, enabling 5G and WiFi connectivity for data offload and a Predetermined Change Control Plan (PCCP) for its AI-powered ScoPilot feature.
Integrations
EHR Not specified
Specialties General Surgery, Obstetrics & Gynecology, Urology

Ratings & Reviews

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Press & Coverage

AI and Technology in Pharma
Moon Surgical secures FDA clearance for Maestro system advancements
Moon Surgical received FDA 510(k) clearance for two key advancements to its Maestro surgical system: active Wi-Fi and 5G connectivity for Maestro Insights, and a Predetermined Change Control Plan (PCCP) for its AI application, ScoPilot. This enables greater connectivity and AI-powered functionality for a more efficient, digitalized operating room.
2025-07
Business Wire
Moon Surgical Announces CE Mark for Its Commercial Maestro System
Moon Surgical announced that the latest version of its Maestro System has received CE Mark under the Medical Device Regulation (EU) 2017/745, featuring automated setup, cloud connectivity, and surgeon-guided hands-free scope control. This milestone aims to broaden the use of robotics in soft tissue procedures and improve patient care.
2023-09
LSI Europe '25
Medical Device Companies to Watch: Moon Surgical Wins FDA Clearance for Commercial Version of Maestrou2122 - LSI Europe '25
Moon Surgical's Maestrou2122 System received FDA clearance for commercial use, marking a significant step in robot-assisted laparoscopic surgery. The system is designed to enhance precision and efficiency, reduce surgeon strain, and improve patient recovery.
2024-06
Surgical Robotics Technology
Moon Surgical Receives FDA Clearance for its Commercial Maestrou2122 System
Moon Surgical announced FDA clearance for the commercial version of its Maestro surgical system, designed to support surgeons and staff in 18.8 million annual soft tissue procedures not currently served by telerobotic systems. The system, equipped with NVIDIA Holoscan, aims to enhance operating room efficiency and provide data-driven insights.
2024-06
Sofinnova Partners
Moon Surgical launches Maestro platform at Lee Health - Sofinnova Partners
Moon Surgical successfully launched its Maestrou2122 Platform at Lee Health's Gulf Coast Medical Center, with over 100 procedures completed, demonstrating excellent clinical and operational outcomes. The Maestro System has now supported over 1,600 procedures worldwide across 60 different types of minimally invasive surgeries.
2025-07
Journal of Surgical Endoscopy
First human surgery using a surgical assistance robotics device for laparoscopic cholecystectomies - PMC
A detailed study in the Journal of Surgical Endoscopy reported successful first-in-human cholecystectomy cases using Moon Surgical's Maestro System, with no significant complications. The Maestro System aims to overcome challenges in conventional and tele-robotic laparoscopic approaches by augmenting the surgeon's performance at the bedside.
2023-08
PR Newswire
Moon Surgical Unlocks the Intelligent OR with Maestro Connectivity and Insights Activation
Moon Surgical announced that all deployed Maestro systems now feature active 5G and Wi-Fi connectivity, enabling real-time analytics across the installed base. This completes Maestro's edge-to-cloud architecture, leveraging NVIDIA Holoscan and NVIDIA IGX for fleet-wide intelligence.
2025-12
BioSpace
Moon Surgical receives FDA clearance for ScoPilotu2122 on Maestro, industry's first AI-enhanced intraoperative capability, powered by NVIDIA Holoscan - BioSpace
Moon Surgical received FDA clearance for ScoPilot, an AI-powered feature on the Maestro System, enabled by NVIDIA Holoscan. ScoPilot ensures a stable and ideal view during surgery, enhancing control, safety, and efficiency by allowing the laparoscope to follow instrument tips seamlessly.
2025-03

Videos

Product demos, reviews, and walkthroughs for Maestro System.

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Frequently Asked Questions

The Maestro System, depending on its specific application (e.g., Moon Surgical's robotic assistant or iEHR Maestro's automation platform), is designed to integrate with existing EHR systems and clinical workflows, often via standard APIs like HL7 and FHIR. It offers AI-powered functionalities such as real-time surgical assistance, automated documentation, enhanced clinical decision support, and streamlined operational tasks.
Maestro Systems prioritize data privacy and security through robust encryption, strict access controls, and audit trails, aiming for full HIPAA compliance. For clinical applications, systems like Moon Surgical's Maestro have received FDA clearance for their AI-enhanced capabilities, while others like iEHR Maestro and MaestroQA are built with HIPAA and CMS guidelines in mind.
Like all AI, Maestro Systems may have limitations related to the scope and diversity of their training data, potentially affecting performance in rare cases or specific patient demographics. Developers continuously monitor for biases, update models with diverse datasets, and provide clear guidelines on intended use, emphasizing that AI should augment, not replace, human expertise.
Depending on its function, the Maestro System differentiates itself through specialized AI algorithms, unique datasets, and tailored features for specific medical domains, such as surgical robotics or clinical workflow automation. While alternatives exist for various healthcare AI applications, Maestro aims to offer a more integrated or specialized solution compared to generic tools or manual processes.
Pricing for Maestro Systems often follows a tiered subscription model, which can vary based on factors like the number of users, specific modules or functionalities utilized, and data volume. Some systems, like Maestro Nutrition Cloud, emphasize competitive pricing adaptable for integration, while others may require direct vendor contact for personalized quotes.
Providers of Maestro Systems typically offer dedicated support teams to assist with technical issues and concerns regarding the AI output. Comprehensive training and resources are also provided to help users understand system functionalities, interpret recommendations, and ensure safe and accurate application, reinforcing AI as a supportive tool.
The Maestro System's AI is trained on extensive and often specialized datasets relevant to its application, such as surgical procedural data for robotics or clinical records for decision support. The quality and diversity of this data are crucial for the AI's accuracy and generalizability, with continuous efforts to ensure broad representation and minimize biases.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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