Iterative Scopes, a pioneer in the development of precision-based gastrointestinal disease technologies, announced today that it has CE marked its SKOUT medical device under the MDD (Directive 93/42/EEC) after successfully completing the assessment of the conformity of the device with the applicable MDD requirements in April 2021. This milestone marked the product’s first regulatory certification and will enable its distribution and marketing in Europe, a key step in Iterative Scopes’ global expansion plans.
SKOUT is an artificial intelligence (AI) driven medical device intended to detect potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
