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

NextEdge Admin

31 Aug 2024

2 min 26 sec

PathAI, a global leader in AI and digital pathology solutions, has announced that its AISightⓇ Dx Image Management System (IMS) has received In Vitro Diagnostic Regulation (IVDR) certification for primary diagnosis. This CE mark enables PathAI to expand its presence in the European diagnostic pathology market, enhancing pathologists' diagnostic accuracy and improving efficiency and quality in anatomic pathology laboratories.

"The IVDR certification reflects our commitment to delivering safe, effective, and high-quality diagnostic tools," said Andy Beck, MD, PhD, co-founder and CEO of PathAI. "This milestone not only confirms the compliance of our AISight platform with European regulations but also strengthens our mission to support pathologists in delivering precise diagnoses and improving patient outcomes across Europe."

AISight Dx is a comprehensive digital pathology platform developed with insights from over 200 pathologists. It streamlines digital pathology workflows with features such as caseload balancing, image ingestion, viewing, collaboration tools, and case management. The platform also integrates seamlessly with laboratory information systems through AISight Link, optimizing workflow efficiency. Anatomic pathology laboratories, including those in health systems, university hospitals, and reference labs, can benefit from AISight’s capabilities.

Nick Brown, Chief Growth Officer at PathAI, expressed excitement about the company's European expansion, aiming to democratize access to digital pathology and enhance the pathologist experience. PathAI will be showcasing AISight at the European Congress of Pathology from September 7 to 11, 2024.

PathAI is dedicated to advancing diagnostic accuracy and operational efficiency in pathology labs through innovative AI and digital solutions.