EndoStart receives FDA clearance for Endorail product to optimize colonoscopy results

Endostart, a medical device company specializing in gastrointestinal endoscopy solutions, announced a major breakthrough as its flagship product, Endorail, received FDA 510(k) clearance. Endorail is a magnetic balloon solution that optimizes colonoscopy results.

The company says this achievement represents a significant step forward in advancing the field of gastrointestinal endoscopy and improving patient care around the world.

Endorail, which is currently commercially available in the United States, is said to provide a solution that increases the efficiency and safety of endoscopic procedures, resolves loops, and facilitates competition in long-duration colonoscopies. Designed to streamline the process of colonoscopy, Endorail combines magnetic balloon solutions with user-friendly features that allow physicians to solve procedural challenges with confidence and precision. The company says it can be overcome.

Endorail gives physicians access to on-demand tools that not only optimize procedure outcomes, but also reduce healthcare costs associated with prolonged or incomplete procedures.

Colonoscopy continues to be a cornerstone procedure in the diagnosis, monitoring, prevention, and treatment of a variety of colon diseases, including colorectal cancer and chronic inflammatory bowel disease.

Dr. Alessandro Tozzi, co-founder and CEO of Endostart, said: “We are thrilled to receive FDA clearance for Endorail. This is an important milestone in our commitment to revolutionizing gastrointestinal endoscopy. It became,” he said. This recognition underscores our commitment to innovation and dedication to improving patient care. We look forward to bringing Endorail to endoscopy centers across the country and providing physicians with the tools they need to deliver superior care.

In 2023, EndoStart conducted a multicenter clinical trial to demonstrate Endorail's high safety and efficacy profile in completing difficult colonoscopies. Study results will be presented at the Digestive Diseases Weekly conference in Washington, DC, May 18-21, 2024.

Dr. Tozzi added: “Through this study, Endostart and our research partners have demonstrated that Endorail is safe and can be effectively used on-demand for patients undergoing long-term colonoscopies.” Future research will be conducted to identify further benefits such as cost benefits and time savings with our device.

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