CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 2021.1 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.2
Using AI-enabled advanced computer vision technology, SKOUT recognizes suspicious tissue and provides real-time feedback to gastroenterologists, that draws their attention to areas of interest. According to clinical studies performed by Iterative Scopes, SKOUT has been demonstrated to confer an increase in Adenomas Per Colonoscopy when compared to historical controls,3 which can potentially have a significant impact to a patient’s risk for colorectal cancer.4
“The CE Mark is the first step of many in Iterative Scopes’ go to market plans to apply AI in gastroenterology,” said Dan Wang, VP of Operations at Iterative Scopes. “SKOUT is our first product and targets colorectal cancer prevention. In addition, Iterative Scopes has developed a deep bench of other AI products which we have the internal strength and rigor in the regulatory domain to bring to market.”
The ability to offer SKOUT to European gastroenterologists continues Iterative Scopes’ rapid growth this year as the company pursues its vision of applying proprietary, cutting-edge AI and computer-vision technologies to improving endoscopy.
A $30 million Series A financing that closed in August 2021 included a roster of top-tier investors and is supporting the company’s near-term goals of building its talent base and attracting major drug developers and other stakeholders that are key to its holistic approach to transforming the GI space.
Iterative Scopes was founded in 2017 as a spin out of the Massachusetts Institute of Technology (MIT) by Jonathan Ng, MBBS a physician entrepreneur, who developed the company’s foundational concepts while he was at MIT and Harvard.
About Iterative Scopes
Iterative Scopes is pioneering the application of precision medicine to gastroenterology with the aim of enhancing colorectal cancer screenings. The technology is also designed to help optimize clinical trials investigating treatment of inflammatory bowel disease. Its powerful, proprietary artificial intelligence and computer vision technologies have the potential to improve the accuracy and consistency of endoscopy readings. Iterative Scopes is initially applying these advances to improve polyp detection for colorectal cancer screenings and standardizing disease severity characterization for inflammatory bowel disease (IBD). Longer term, the company plans to establish more meaningful endpoints for GI diseases, which can be better predictors of therapeutic response and disease outcomes. Spun out of MIT in 2017, the company is based in Cambridge, Massachusetts.
SKOUT™ is not available for sale in the United States. 510(k) pending.
1 The medical device can validly be CE marked and commercialized in the European Union under the transitional provisions of the Medical Devices Regulation which started to apply on 26 May 2021.
2 SKOUT is intended to be used as a tool to provide additional information for endoscopic observation to assist endoscopists with potential colorectal polyp detection during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. It is not intended to provide primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients.
3 Data on file
4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4036494/
