The US market authorisation follows a multicentre clinical trial designed to demonstrate the safety of the Endorail device. Credit: Shutterstock / Roman Zaiets.

Italian medical device company Endostart has secured US Food and Drug Administration (FDA) 510(k) clearance for its colonoscopy device, which is designed to optimise prolonged gastrointestinal procedures.

Named Endorail, the US market authorisation follows a multicentre clinical trial designed to demonstrate the safety of the device, which uses a magnetic balloon system to streamline prolonged colonoscopies with the additional goal of reducing cost.

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According to GlobalData’s Medical Intelligence Centre, the global colonoscope market is forecast to grow beyond $4.4bn by the end of 2030. The US currently makes up more than 16% of the global market with this growth being driven by an increasing number of colonoscopies being performed, both as the primary screening method and as a follow-up colonoscopy.

Endostart co-founder and CEO Alessandro Tozzi said: “Through this study, Endostart and our research partners have established that Endorail is safe and can be used effectively on demand in patients with prolonged colonoscopies. Future studies will be carried out to identify additional benefits, including cost advantages and time-saving with our device.”

The endoscopic device market in the US already presents stiff competition for the relatively newly founded Italian company. Japanese competitors Fujifilm and Olympus Corp dominate the market with shares of 14.5% and 30.4% respectively, according to a GlobalData market model.

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Tozzi added: “We are thrilled to obtain FDA clearance for Endorail, marking a significant milestone in our journey to revolutionise gastrointestinal endoscopy. This clearance underscores our commitment to innovation and our dedication to improving patient care. We look forward to introducing Endorail to endoscopic centres across the United States, empowering physicians with the tools they need to deliver exceptional care.”

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Elsewhere in the field of endoscopic devices, Fujifilm has been able to similarly acquire FDA 510(k) clearance for its AI-driven endoscopic imaging detection system named CAD EYE. At the same time, Israeli company Magentiq Eye has published results from a trial designed to validate its computer-aided detection colonoscopy tool named the Magentiq-Colo CADe.