De Novo grant awarded to first ever co-op powered ENT surgical robotic assistant

Editor's Note

Baltimore, MD-based Galen Robotics, Inc has secured US Food and Drug Administration De Novo classification grant and authorization to market the Galen ES® Robotic System, a cooperative powered surgical assist device for ear, nose and throat (ENT) surgery, for rigid microlaryngeal procedures.

“Galen will be the first surgical robotic company to launch as a service under the name Digital Surgery as a Service (DSAAS™),” stated David Saunders, co-founder and CTO of Galen Robotics, Inc.

The robotic assistant facilitates procedures and works in tandem with the surgeon’s movements to assist in precise and stable positioning of an instrument, including Microlaryngeal Alligator Forceps (MAF), while the surgeon maintains direct physical control. The Galen ES is indicated to be used in rigid microlaryngeal procedures where the MAF would be utilized by an otolaryngologist in patients 18 years or older.

“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,” said Bruce W. Lichorowic, president and CEO of Galen Robotics, Inc. “We anticipate significantly improved surgical precision and better patient outcomes.”