Moon Surgical wins first FDA 510(k) clearance for surgical robot
Moon Surgical announced today that it received FDA 510(k) clearance for its Maestro surgical robotics system.
Paris- and San Francisco-based Moon Surgical designed Maestro to support surgeons in soft tissue surgical procedures. Think of it as a robotic surgical assistant.
The small, adaptable system can integrate into existing clinical workflows. It features capabilities that bolster operating room efficiency and allow for alternative labor models, the company said.
In June, Moon Surgical completed a $31.3 million Series A fundraising. CEO Ann Osdoit said the company aims to make Maestro capable of use in any laparoscopy in any operating room. This could revolutionize minimally invasive surgery through collaborative and adaptive robotics.
“The clearance of Maestro by the FDA is a significant step forward on this path,” Osdoit said. “It enables select high-volume surgical centers in the U.S. and the patients they serve to gain access to the capabilities offered by Maestro. It will also provide us with invaluable insights about its use in a real-life setting.”
The company said it is currently finalizing the development of its first commercial system.
“We have seen tremendous interest from surgical practices in the U.S. and are eager to see surgeons and their staff using Maestro for the benefit of their patients in that geography,” said Professor Brice Gayet, laparoscopist and co-founder of Moon Surgical. “Maestro will dramatically change the way in which the standard of care is performed in soft tissue surgery, for millions of patients each year.”
Source: https://www.massdevice.com/moon-surgical-fda-510k-clearance-surgical-robot/
