PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, has announced that its AISight Dx Image Management System (IMS) is In Vitro Diagnostic Regulation (IVDR) certified for use in primary diagnosis.
The CE mark paves the way for the company’s expansion in the European diagnostic pathology market, enhancing pathologists’ interpretations and driving efficiencies 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.”
AISight Dx is a digital pathology platform meticulously designed with input from over 200 pathologists to streamline end-to-end digital pathology workflows. It offers a suite of features including ‘best-in-class’ caseload balancing and assignment, image ingestion, image viewing, collaboration tools, and image and case management according to the company.
The platform can also seamlessly integrate bi-directionally with laboratory information systems through AISight Link, further enhancing workflow efficiency. Anatomic pathology laboratories of all sizes and specialties, including health systems, university hospitals, and reference laboratories – can leverage the benefits of AISight.
“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 democratise access to digital pathology, enhance the pathologist experience, and ultimately improve patient outcomes,” said Nick Brown, Chief Growth Officer at PathAI.
