Endostart, a medical device company specializing in gastrointestinal endoscopy solutions, has received FDA 510(k) clearance of its flagship product, Endorail.
Now commercially available in the U.S., Endorail enhances the efficiency and safety of endoscopic procedures, offering a solution to solve looping and facilitate the completion of prolonged colonoscopies. Designed to streamline the colonoscopy process, Endorail combines its magnetic balloon solution with user-friendly features.
In 2023, Endostart conducted a multicenter clinical trial to demonstrate the high safety and efficacy profile of Endorail in the completion of difficult colonoscopies. The results of this study will be presented at the Digestive Disease Week Congress, taking place in Washington DC, (US), May 18 – 21, 2024.
With FDA clearance secured, the company is positioned to expand its footprint in the U.S.
