University of Louisville Health is one of the first U.S. health systems to implement FDA-approved Paige Prostate
NEW YORK--(BUSINESS WIRE)--Paige, the global leader in AI-based diagnostic software in pathology, today announced that University of Louisville (UofL) Health, a leading academic health system based in Louisville, Kentucky, has deployed a full suite of Paige AI-enabled digital pathology software to improve diagnostic confidence, efficiency, and patient care during routine cancer diagnosis.
UofL Health is one of the first health systems in the U.S. to implement Paige Prostate, the first and only AI-based pathology product to receive FDA approval for in vitro diagnostic (IVD) use in detecting cancer in prostate biopsies. UofL Health will also deploy Paige’s FullFocus® as their digital pathology case management tool and digital pathology image viewer, and Paige Breast to elevate pathologists’ ability to diagnose cancer.
With cancer cases on the rise globally, AI technologies have the potential to help pathologists work more confidently and efficiently. AI can act as a second pair of eyes for pathologists, helping them to quickly spot very small, almost imperceptible regions of cancer in a tissue sample that may be challenging to recognize with the naked eye. This can translate into better accuracy in cancer diagnosis and ultimately better clinical management for patients.
“We are proud to be one of the first health systems in the U.S. to adopt an AI-enabled digital pathology software platform which offers an enhanced look at tissues and acts as a built-in second opinion in our routine diagnostic processes,” said Dibson Dibe Gondim, M.D., Director of Pathology Informatics, Assistant Professor of Pathology and Laboratory Medicine, Associate Residency Program Director of Anatomic Pathology, and Director of Genitourinary Pathology at the University of Louisville School of Medicine. “Leveraging the Paige Platform and AI tools, such as Paige Prostate, will help us increase efficiency and diagnostic confidence for our patients and improve our pathology workflows.”
Additionally, UofL Health will leverage Paige’s Software Development Kit, an open platform that enables institutions to deploy customized laboratory developed tests for digital pathology, to deploy AI algorithms to assist in operational efficiencies and image analysis that were developed in-house.
“Completing our deployment at University of Louisville Health is an exciting milestone for Paige as we help hospital systems adopt digital, AI-based technologies to make their existing workflows more accurate and efficient,” said Andy Moye, Ph.D., Chief Commercial Officer at Paige. “We are proud to offer a robust portfolio of AI-enabled digital pathology technologies backed by the FDA. We are also excited to see how the University of Louisville is utilizing the Paige Software Development Kit to achieve near-term clinical impact, and we hope this will be the first of many research applications adopting our open technology to improve patient care.”
Outside of the U.S., Paige Prostate is CE-marked for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK. FullFocus is FDA cleared and CE-marked. The products are otherwise available for research use only in other territories.