Galen Robotics wins FDA de novo nod for ear, nose, throat surgical robot

[Image from the Galen Robotics website]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…

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  • September 26, 2023
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Galen Robotics closes $15M oversubscribed Series A

Digital-surgery-as-a-service company Galen Robotics announced today that it closed an oversubscribed Series A round worth $15 million.

Baltimore-based Galen Robotics, founded in 2016, develops a collaborative soft tissue surgical robot. It aims to become the first surgical robot company to launch “as-a-service” using the per-usage disposable model. The company submitted its surgical robot to the FDA for consideration.

This represents an effort to “level the surgical playing field,” according to a news release. Galen Robotics says its platform could erase large capital expenditures associated with today’s surgical robots. Once cleared, Galen Robotics intends to make its platform available for minimally invasive procedures. It first has its eye on laryngological procedures. Further indications could include ENT, neurosurgery, spine and cardiothoracic procedures.

Galen Robotics received an investment in its Series A from Ambix …

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  • November 1, 2022
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