Galen Robotics has secured the US Food and Drug Administration (FDA) De Novo classification grant and authorisation to commercialise the Galen ES Robotic System for rigid microlaryngeal procedures usage.

Galen ES Robotic System is a cooperatively powered surgical assist device for ear, nose, and throat (ENT) surgery.

The robotic platform, said to be the first of its kind, is intended to ease ENT surgical procedures, including instrument placement in combination with Microlaryngeal Alligator Forceps.

US-based Galen Robotics, a Digital-Surgery-as-a-Service (DSaaS) provider, has designed the device to work in conjunction with the surgeon’s movements for precise and steady instrument positioning while maintaining the surgeon’s direct physical control over the tool.

Galen Robotics president and CEO Bruce W Lichorowic said: “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.”

“Achieving this milestone with $25m in funding during Covid is truly remarkable compared to other medical device companies who are spending hundreds of millions to achieve the same goal.

“The Galen ES System holds great promise in revolutionising 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.”

The robotic system has the potential to provide instrument stability in difficult microlaryngeal procedures, the company claimed. Its cutting-edge functionality and rapid setup time are designed to improve otolaryngologists’ abilities and result in better patient outcomes.

The robotic system’s original technology is based on a license from a long-standing research partnership between Galen Robotics and Johns Hopkins Technology Ventures.

Galen Robotics anticipates using the De Novo approval from the American health regulator to advance surgical medicine, transform surgical methods, and offer advanced solutions to healthcare professionals.

The DSaaS provider aims to offer practical support during surgeries performed in narrow corridors where delicate structures must be treated with extreme care.

According to the company, the Galen ES is indicated to help move the specified Microlaryngeal Alligator Forceps to a position in the surgical field chosen by the surgeon and hold that position until the operator moves it to a different location.