Moon Surgical has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for enhancements to its Maestro System, focusing on connectivity and artificial intelligence (AI) developments.
This approval includes enhanced connectivity features via Wi-Fi and 5G, facilitating data exchange with the cloud-based Maestro Insights platform, according to Moon Surgical.
The Maestro Insights platform provides surgical teams and administrators access to procedural data analytics. The platform enables users to monitor utilisation, track progress towards both individual and facility-wide objectives, and manage scheduling while optimising resources and workflows across various locations.
Moon Surgical CEO Anne Osdoit said: “Connectivity unlocks a new layer of value for our customers.
“With Maestro Insights, surgical teams gain a clearer understanding of their practice, and hospitals gain the tools to better manage and scale their surgical services. It’s the next step in making data-driven surgery a practical reality.”
Additionally, the FDA has approved a Predetermined Change Control Plan (PCCP) for ScoPilot, Maestro’s AI-powered feature that integrates physical AI capabilities. This plan allows Moon Surgical to efficiently develop, test, and deploy new versions of ScoPilot.
The ScoPilot feature enables real-time laparoscope control using the surgeon’s instrument movements, aiming to improve surgical efficiency by maintaining flow and focus without disengagement.
The dual clearance represents a key advancement for Moon Surgical in expanding the functional capabilities of its Maestro System. The system is designed to enhance the delivery of minimally invasive surgery by providing actionable insights and improving resource management through its cloud platform.
Moon Surgical chief strategy officer Jeff Alvarez said: “The PCCP clearance marks a pivotal moment for Physical AI.
“It opens the door to an entirely new pace of innovation; allowing us to continuously expand what ScoPilot can do and accelerate how Maestro elevates surgical teams in the OR.”
The Maestro System, which received FDA clearance in June 2024, has been implemented in over 1,100 surgeries across the US and Europe. It supports various types of surgeries, including general, bariatric, gynaecologic, and urologic procedures.
The system leverages NVIDIA Holoscan technology to run AI applications within the operating room environment.
