Moon Surgical today announced it received FDA 510(k) clearance for two new features on the Maestro robotic surgical assistant.
The clearances cover connectivity of the platform to power the Maestro Insights product and a Predetermined Change Control Plan (PCCP) to evolve its AI-powered ScoPilot product.
Maestro can now use active Wi-Fi and 5G connectivity, allowing for seamless data exchange with the company’s cloud-based platform, Maestro Insights. The platform gives clinicians access to insights from procedural data and allows users to track utilization, monitor progress toward individual and facility-wide goals.
“Connectivity unlocks a new layer of value for our customers,” CEO Anne Osdoit said in a news release. “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.”
Moon Surgical’s PCCP for ScoPilot is a Physical AI application that is integrated into Maestro platforms. ScoPilot allows for seamless laparoscope control through real-time movement of the surgeon’s instruments. It also allows the company to build, test and safely deploy future versions of ScoPilot.
“The PCCP clearance marks a pivotal moment for Physical AI,” Chief Strategy Officer Jeff Alvarez said. “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.”
