Wision A.I. Seeks CE-MDR approval for medical colonoscopy device with AI-powered diagnostic software
SHANGHAI, Nov 15, 2021 / PRNewswire / - Wision A.I. Ltd, recently formed to develop AI diagnostics for gastrointestinal endoscopy, today announced that it has received the CE mark approval for its AI-powered EndoScreener colonoscopy polyp detection software. This is the first certificate confirming the European mark of conformity (CE) class II according to the new Medical Device Regulation (MDR 2017/745).
Outstanding product performance with compelling clinical evidence
Compared to the previously self-proclaimed Class I devices for the automatic detection of polyps during colonoscopy [1], the EndoScreener has an overwhelming advantage in terms of clinical evidence from a randomized controlled trial (RCT). EndoScreener has been shown to be effective in improving the detection rate of adenomas in more than 5,000 patients in six strictly controlled randomized trials, including three open-label RCTs [2], [3], one double-blind RCT [4], and two tandem colonoscopic RCTs [5] , [6]. In the most recent published multicenter tandem colonoscopy study conducted at four leading medical research institutions in the United States, EndoScreener provided a 41% reduction in the failure rate in the detection of precancerous conditions (adenomas and sessile denticles) (19.13 vs. 32.52 p = 0, 0047), as well as an improvement in the ratio of detected adenomas to index colonoscopy (APC) by 33% (0.9000 vs. 1.1947 p = 0.323). Even with a high median adenoma detection rate (ADR) of 43.64% in screening / follow-up of the clinical group according to standard clinical practice, no satiety effect was found in this study.
Advanced AI technology in the medical field is being introduced to the European market
Colorectal cancer (CRC) is a widespread malignant neoplasm in humans. In 2020, more than 1.9 million new cases of the disease were detected worldwide, and the number of deaths was 935 thousand. It is also the second most deadly cancer in Europe, with one European dying from CRC every 3 minutes. Detecting and removing adenomatous polyps with early diagnosis and regular colonoscopic screening is the most effective way to reduce the incidence and death of colorectal cancer. Opening up the European market for EndoScreener will ultimately contribute to the prevention of colorectal cancer, saving health services resources and reducing costs in the countries concerned. Wision A.I. is open to collaboration with country partners to accelerate the availability of the tool across the EU.
High level of compatibility and ease of implementation
EndoScreener is a real-time automated diagnostic software that helps endoscopists provide visual and audible alerts when polyps are detected during colonoscopy. The EndoScreener, a purely software medical device (SaMD) with a relatively economical total cost of ownership (TCO), is compatible with most widespread endoscopy systems When combined with the proper hardware in mainstream computers, this AI software can be deployed with great flexibility in a variety of clinical environments for colonoscopy
About Wision A.I.
Wision A.I. has extensive experience in the development of mathematical models and algorithms. It integrates medical knowledge into general-purpose and scalable models using state-of-the-art convolutional neural networks and non-specialized computation to achieve robust performance in detecting problems in diagnostic imaging.