PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, has announced that its AISightⓇ Dx Image Management System (IMS) has been certified under the In Vitro Diagnostic Regulation (IVDR) for primary diagnosis. This new CE Mark certification positions the company to expand into the European diagnostic pathology market, aiming to improve the accuracy and efficiency of pathologists' interpretations and drive significant quality improvements in 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 comprehensive digital pathology platform developed with input from over 200 pathologists to optimize end-to-end digital pathology workflows. Key features of the platform include caseload balancing and assignment, image ingestion, image viewing, collaboration tools, and image and case management. Additionally, the platform integrates seamlessly with laboratory information systems via AISight Link, further enhancing workflow efficiency. This makes AISight Dx beneficial for anatomic pathology 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.
The announcement of this certification is significant for the medical community as it highlights the potential for improved diagnostic accuracy and operational efficiencies in pathology labs across Europe. The integration of advanced AI and digital tools in the healthcare sector is expected to lead to quicker and more precise diagnoses, thereby improving patient outcomes. PathAI's expansion into the European market underscores the growing importance of digital pathology solutions in modern medical diagnostics.
PathAI will showcase the AISight Dx Image Management System at the European Congress of Pathology from September 7 to 11, 2024. Attendees can learn more about the platform and see a demo at booth #L145.
