FDA Grants Breakthrough Device for AI Pathology

FDA has granted Paige.AI, a start-up company that says it is developing computational pathology focused on artificial intelligence (AI) to transform clinical diagnosis and cancer treatment, a breakthrough device designation. “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,” the company says.

Paige.AI was launched in early 2018 based on technology developed by its founders and a license agreement with Memorial Sloan Kettering Cancer Center, which had begun digitizing its pathology slides four years ago. Under the license, the company says it receives de-identified images of digitized slides — more than one million so far — and is funding the digitization of an additional four million archive slides.