EndoVigilant announced today (Announcement) that the pivotal clinical study for its first application using its AI enabled medical imaging platform is now in progress at multiple sites across the US. The first application focuses on real-time computer aided detection (CADe) assistance for improving polyp detection during colonoscopies.
EndoVigilant’s first application has been developed to assist gastroenterologists in real-time with polyp detection with the goal of reducing adenomatous polyp miss rate and hence, the occurrence of interval colon cancers. EndoVigilant’s software has been developed using state of the art deep learning AI algorithms and is trained on images and videos collected from practicing gastroenterologists from multiple academic and private endoscopy centers across the US. It is interoperable with existing endoscopy systems and can be deployed in a plug-and-play manner without requiring changes or costly upgrades to those systems.
Earlier this year, EndoVigilant reached an agreement with the FDA on the design of its pivotal clinical study. The study is a prospective, multi-center, randomized controlled trial with sites and investigators from both academic and community settings. The study is currently being performed to support the company’s planned filing to the FDA to obtain market clearance in the US.