Daily Newsletter

27 September 2023

Daily Newsletter

27 September 2023

Galen receives De Novo authorisation from US FDA for ENT robotic system

The system helps improve patient outcomes by enhancing otolaryngologists' capabilities with advanced functionality.

RanjithKumar Dharma September 27 2023

Galen Robotics has received a De Novo classification grant and authorisation from the US Food and Drug Administration (FDA) for its Galen ES Robotic System.

The authorisation will enable the marketing of the device for use in rigid microlaryngeal procedures.

The new cooperatively powered surgical assist device is intended for ear, nose and throat (ENT) surgery.

It can be used for ENT surgical procedures including instrument placement along with microlaryngeal alligator forceps.

The device aligns with the surgeon's movements for accurate and stable positioning of an instrument while maintaining the surgeon's direct physical control of the instrument.

Galen ES also provides the potential for instrument stability in critical microlaryngeal surgeries.

It aims to improve patient outcomes by enhancing otolaryngologists' capabilities with advanced functionality and quick set-up time.

Galen ES’ original technology is licensed from a continuing research partnership between Galen Robotics and Johns Hopkins Technology Ventures.

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

Galen, which was established in 2016, is the pioneer of digital-surgery-as-a-service (DSaaS).

Generative AI set to transform the medical devices industry

Generative AI can improve personalized healthcare by collecting data from patients via wearable devices, which can provide continuous, real-time data that can complement traditional data sources such as imaging, patient records, and more. It can also enhance existing imaging techniques by generating high-quality images of organs using data from low-resolution images (such as ultrasounds). However, the collection and use of patient healthcare data through AI medical products could conflict with regulations around the globe.

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