Paige.AI's Prostate Cancer Platform Granted Breakthrough Device Status

Paige.AI is working with a pathology dataset to develop a comprehensive portfolio of AI products across cancer subtypes.

Today, the U.S. Food and Drug Administration (FDA) granted breakthrough device designation to Paige.AI, a computational pathology startup focused on building artificial intelligence (AI) to aid in the clinical diagnosis and treatment of cancer.

“Paige.AI is focused on providing (AI) 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,” said Leo Grady, Ph.D., CEO of Paige.AI.

The startup, launched in 2018, builds clinical-grade AI in an attempt to revolutionize the treatment of cancer, improve patient outcomes and provide new insights for researchers.

Paige.AI is putting together a comprehensive suite of products, and its first is focused on prostate cancer. Among its machine learning models are Paige Guidance Engine, which could help tasks like rapid diagnostic stratification and tumor detection, and Paige View, which has been rolled out institution wide at Memorial Sloan Kettering Cancer Center for pathologists and cancer researchers.

The company has access to Sloan Kettering’s digitized pathology slides and is funding the digitization of an addition four million archive slides to develop a comprehensive portfolio of AI products across cancer subtypes.

The FDA’s breakthrough device designation is granted for technologies that could provide a more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases.

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