PathAI's AISight Dx Image Management System Receives CE Mark for Primary Diagnosis

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, announced that its AISightⓇ Dx Image Management System (IMS) has received In Vitro Diagnostic Regulation (IVDR) certification for use in primary diagnosis. The newly acquired CE mark facilitates PathAI's expansion into the European diagnostic pathology market, aiming to improve pathologists' interpretations and drive efficiency and quality improvements within anatomic pathology laboratories.

'The IVDR certification demonstrates PathAI’s unwavering commitment to providing safe, effective, and high-quality diagnostic solutions,' said Andy Beck, MD, PhD, co-founder and CEO of PathAI. 'It not only confirms the compliance of our AISight platform with the latest European regulations but also strengthens our ability to assist pathologists in delivering accurate diagnoses and improving patient outcomes across Europe.'

The AISight Dx platform is a comprehensive digital pathology solution developed with input from over 200 pathologists. It streamlines end-to-end digital pathology workflows with features such as caseload balancing, image ingestion and viewing, collaboration tools, and case management. AISight Dx can also integrate with laboratory information systems through AISight Link, enhancing workflow efficiency for laboratories of all sizes and specialties, including health systems, university hospitals, and reference laboratories.

'We are thrilled to expand our focus to bring the AISight Dx Image Management System to European labs. We look forward to partnering with European labs to democratize access to digital pathology, enhance the pathologist experience, and ultimately improve patient outcomes,' said Nick Brown, Chief Growth Officer at PathAI.

PathAI will be showcasing their AISight Dx platform at the European Congress of Pathology from September 7 to 11, 2024. This event will provide an opportunity for European labs to explore the capabilities of AISight and its potential impact on diagnostic practices.

By achieving CE Mark certification, PathAI's AISight Dx Image Management System is poised to revolutionize the pathology field in Europe, setting new standards for diagnostic accuracy and operational efficiency. This development is likely to have significant implications for pathology laboratories, healthcare providers, and ultimately, patient care across Europe.