Search Results for 'U.S. FOOD AND DRUG ADMINISTRATION'

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Signum Surgical publishes positive first-in-human results for BioHealx® device

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Signum Surgical, a Galway-based medical technology company dedicated to advancing the treatment of colorectal diseases, this week announced the publication of first-in-human clinical data for its BioHealx® Anal Fistula Device in the International Journal of Colorectal Disease.

Galway-based Signum Surgical gets FDA approval for innovative device

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Galway-based Signum Surgical — a medical technology company developing innovative solutions to treat colorectal diseases, has confirmed that its BioHealxTM technology has been granted marketing clearance by the U.S. Food and Drug Administration (FDA), as a first-of-its-kind medical device for the treatment of anal fistula.

 

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