4 July 2024

~1 minutes read

FDA approval for surgical device developed by Galway city based company

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FDA approval for surgical device developed by Galway city based company

Signum Surgical, a Galway city based medical technology company has been granted FDA approval for a device which treats colorectal diseases.

The U.S. Food and Drug Administration has given marketing clearance for the BioHealxTM surgical technology.

The milestone follows recent completion of clinical trial evaluating the safety and efficacy of the single use implant.

Peter Ónody, Colorectal Surgeon, says this treatment has the potential to eliminate the need for multiple surgeries.

Signam Surgical Limited is based at New Docks in the city.

It was founded in 2016 by Eoin Bambury and Moshe Zilversmit as a spin-out of the NUIG BioInnovate programme.

 

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