Boston, MA – August 28, 2024 – PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today 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 robust 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. 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 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 exhibiting at the European Congress of Pathology from September 7 to 11, 2024. To learn more about AISight and see a demo, visit us at booth #L145 or email digitaldx@pathai.com.
About PathAI:
PathAI is a leading provider of integrated AI and digital pathology solutions, dedicated to transforming diagnostic accuracy and operational efficiency in pathology labs worldwide. Through innovative technologies and strategic partnerships, PathAI aims to enhance patient outcomes and drive the future of medical diagnostics.
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