publication date: Mar. 8, 2019

Drugs & Targets

Paige.AI receives FDA Breakthrough Device designation

Paige.AI, a start-up in computational pathology focused on building artificial intelligence received the Breakthrough Device designation from FDA.

According to Paige.AI, this is the first such designation for AI in cancer diagnosis publicly announced by any company.

“Paige.AI is focused on providing artificial intelligence tools to pathologists that will enable them to become faster and more accurate in their diagnosis and treatment recommendations for the care of cancer patients,” Leo Grady, CEO of Paige.AI, said in a statement.

The FDA’s Breakthrough Device designation is granted for technologies that have the potential to provide for more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases, where timely availability is in the best interest of patients because no approved alternative exists or because the technology offers significant advantages over existing approved alternatives.

The Breakthrough Device program was created by the 21st Century Cures Act.

Paige.AI was launched in early 2018 based on technology developed by Thomas Fuchs, co-founder of Paige.AI, and his colleagues and a license agreement with Memorial Sloan Kettering Cancer Center. MSK began digitizing its pathology slides four years ago.

Under the license agreement, Paige.AI receives de-identified images of digitized slides—more than one million such slides to date—and is funding the digitization of an additional four million archive slides, which in total will create the largest digital pathology dataset.

Paige.AI is working with this de-identified dataset to develop a comprehensive portfolio of AI products across cancer subtypes to serve the needs of pathologists around the world.


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