Galen Robotics announced today that the FDA granted it de novo classification for its Galen ES robotic surgery system.
The de novo nod authorizes the use of Galen ES in rigid microlaryngeal procedures.
Baltimore-based Galen Robotics designed the system as a cooperatively powered surgical assistant for ear, nose and throat (ENT) surgery. It facilitates ENT procedures, including instrument placement, in conjunction with microlaryngeal alligator forceps.
According to a news release, the device works in tandem with surgeons’ movements. It assists with the precise and stable positioning of an instrument while maintaining direct physical control.
“Our team is incredibly proud the Galen ES Robotic System was granted FDA clearance in record time,” said Bruce Lichorowic, president & CEO of Galen Robotics. “With our de novo granted, Galen looks forward to further advancing the field of surgical robotics, revolutionizing surgical techniques, and providing innovative solutions to healthcare professionals.”
Lichorowic added that the company has brought in $25 million in funding. He highlighted that it came in over the course of the COVID-19 pandemic. The company announced a $15 million funding round last November.
“The Galen ES System holds great promise in revolutionizing challenging ENT surgeries by providing existing surgical instruments with its advanced features that empower skilled ENT surgeons. We anticipate significantly improved surgical precision and better patient outcomes.”
More about the Galen Robotics system
The system offers the potential for instrument stability in challenging microlaryngeal surgeries. Its advanced functionality and quick setup time could enhance the capabilities of otolaryngologists.
Galen based its technology on a license from research between the company and Johns Hopkins Technology Ventures. It intends for the system to assist in the movement of the specified microlaryngeal alligator forceps. These move to a surgeon-selected position within a surgical field and remain in place until moved elsewhere by the operator.
The robotic system holds an indication for use in rigid microlaryngeal procedures where those forceps would be utilized by an experienced, trained otolaryngologist. Uses extend to microlaryngeal surgery in an OR environment for patients at least 18 years of age.
Galen Robotics says it hopes the system provides valuable assistance during narrow corridor surgeries with limited space. These surgeries include delicate structures that need delicate handling.
The company made its system available and already accepted orders for the robot. Deployment to leading surgical centers nationwide is underway.
“Galen will be the first surgical robotic company to launch as a service under the name digital surgery as a service (DSAAS),” said David Saunders, co-founder and chief technology officer. “The development of DSAAS is the result of years of dedicated effort, focused on expanding to various microsurgical procedures, facilitating widespread adoption across the medical community.”