Moon Surgical announced FDA 510(k) clearance for two new features of its Maestro surgical robot system.
The approvals cover the platform’s new active Wi-Fi and 5G connectivity, enabling seamless data exchange with Moon Surgical’s cloud-based Maestro Insights platform. This platform provides surgical teams with procedural insights and tools to track utilization and performance at individual and facility levels.
Additionally, Moon Surgical received clearance for a Predetermined Change Control Plan (PCCP) for its AI-powered ScoPilot product. ScoPilot enables intuitive laparoscope control by translating surgeon instrument movements in real time. The PCCP allows the company to safely build, test, and deploy future updates more rapidly.
“Connectivity unlocks a new layer of value for our customers,” said CEO Anne Osdoit. Chief Strategy Officer Jeff Alvarez called the PCCP clearance “a pivotal moment for Physical AI” and a catalyst for accelerated innovation.
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