Invendo Medical said today it won CE Mark approval in the European Union for its Invendoscope SC200, which it touts as the world’s 1st sterile, single-use colonoscope.
The German company said its device is designed to eliminate the complex reprocessing of endoscopes that create a serious risk of cross-contamination and the culturing of resistant bacteria.
“Our revolutionary technology uniquely addresses the significant challenges associated with the cleaning and disinfecting of traditional reusable endoscopes by providing an ergonomically advanced endoscope that offers both sterility and single use. The CE Mark is a significant accomplishment for our company, which enables us to provide endoscopists in Europe with a more advanced technology to perform colonoscopies and a system that enhances patient safety over current devices,” CEO Timo Hercegfi said in a press release.
The company said its Invendoscope SC200 won FDA 510(k) clearance earlier this year, and expects a market introduction of the scope in 2017.