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Published on: Jul 31, 2025

EvoEndo® Endoscopy System Receives FDA Clearance for All Ages

Ridhima Sharma

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DENVER--(BUSINESS WIRE)--EvoEndo®, Inc. (EvoEndo) announces that the EvoEndo® Model LE Gastroscope is now FDA-cleared for patients of all ages — from neonates to adults. Since 2022, the EvoEndo System has been the only option available for sedation-free transnasal endoscopy for pediatric patients five and older. Now, the expanded indication makes safe, transoral endoscopy available to infants and young children, a previously underserved population. In just three years, EvoEndo has redefined what’s possible – and who it’s possible for.

 

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