“The approval is a landmark achievement in the field of digital pathology and demonstrates how robust our technology is when faced with the broad range of natural variations in tissue slides encountered in day-to-day clinical practice,” said Leo Grady, Ph.D., Chief Executive Officer of Paige. “We are grateful for everyone at Paige and our clinical partners who have brought this new generation of computational pathology products to reality.”
Paige Prostate is now available for diagnostic use in the U.S.
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.
About Paige
Paige was founded in 2017 by Thomas Fuchs, Dr.Sc., David Klimstra, M.D. and colleagues from Memorial Sloan Kettering Cancer Center (MSK). The company builds computational pathology products designed so patients and their care teams can make effective, more informed treatment decisions. With this new class of AI-based technologies positioned to drive the future of diagnostics, Paige created a platform to deliver this novel technology to pathologists to transform their workflow and increase diagnostic confidence and productivity. Paige’s products deliver insights to pathologists and oncologists so they can arrive efficiently at more precise diagnoses for patients. Paige is the first company to receive FDA approval for an AI-based digital pathology product.
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