Galen Robotics Celebrates FDA De Novo Clearance, Reflects on the Journey

In late July, Galen Robotics, headquartered in Baltimore, received thrilling news from the U.S. Food and Drug Administration (FDA). Following five years of dedication and commitment to their innovation, the team received an FDA De Novo Grant for the Galen Surgical Robot – 77 days ahead of the national average. With this new FDA approval, the Galen team is primed to introduce their surgical robot and new “Digital-Surgery-as-a-Service™” platform into hospitals.

Galen’s innovative technology is designed for surgeons specializing in microsurgery – a realm of extraordinarily precise procedures that tolerate minimal margin for error.