Augere Medical Secures MDR CE-mark for its PolypAId™ Software and System
The MDR CE-mark is an important milestone for Augere Medical, enabling European launch of Augere’s PolypAId™ System for artificial intelligence (AI) assisted detection of polyps during colonoscopy colon cancer screening.
After more than 10 years of basic research, product and clinical development, the Medical Device Regulation (MDR) CE-mark is a crucial milestone and enables Augere Medical to start commercial launch in geographies accepting the MDR CE-mark. The basic research originated from clinical needs identified by leading Scandinavian clinicians and research organizations which laid the fundament for Augere’s platform for AI assisted systems.
David Borge Larsen, Augere’s interim CEO, commented: “This regulatory approval for PolypAId™ is a major milestone for Augere and we have been working hard to achieving the MDR CE-mark over the last years. We are excited to start the commercialization of PolypAId™, working with clinicians and healthcare providers to augment screening of colorectal cancer and in general to increase prevention of bowel cancer and thereby improving patient care.”
According to the World Health Organization, colorectal cancer (CRC) is the third most common cancer worldwide accounting for approximately 10% of all cancer cases. In 2020, more than 1.9 million new cases of CRC were reported, and more than 930,000 deaths were estimated worldwide. By 2040 the burden of CRC will increase to 3.2 million new cases per year (an increase of 63%) and 1.6 million deaths are expected per year (an increase of 73%).
Early detection of CRC and the precursors, polyps, through colonoscopy screening is regarded as the most effective way to decrease incidence rates and deaths, together with life-style changes. AI assisted colonoscopy screening enables healthcare systems to standardize polyp detection methods and optimize polyp detection rates across hospitals. Recent studies document that AI assisted screening improves polyp detection rates and Augere aims to be a trustworthy partner to work towards this goal.
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Jon H. Hoem
Executive Chair
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About Augere Medical
Augere Medical is a commercial stage Norwegian medical device company founded in 2018 and is developing systems based on Artificial Intelligence (AI) to improve polyp detection rates during screening for colorectal cancer. Augere’s first product, the PolypAIdTM System, is being developed in cooperation with leading colonoscopists and in close cooperation with the research group at Simula. The PolypAIdTM System analyses the real-time video stream during colonoscopy screening and supports the physicians in making the right decision during the screening process. The company has received public grants from Innovation Norway and the Research Council of Norway and has now started the European launch of the PolypAIdTM System.