Regulatory Focus™ > News Articles > 2019 > 3 > Paige.AI Nabs FDA Breakthrough Device Designation for First AI-driven Cancer Diagnosis

Paige.AI Nabs FDA Breakthrough Device Designation for First AI-driven Cancer Diagnosis

Posted 08 March 2019 | By Ana Mulero 

Paige.AI Nabs FDA Breakthrough Device Designation for First AI-driven Cancer Diagnosis

Startup Paige.AI said Thursday it has received US Food and Drug Administration (FDA) breakthrough device designation for use of its artificial intelligence (AI) in cancer diagnoses. 

The move marks the first breakthrough device designation for AI in the diagnosis of cancer. The New York-based startup was just launched early last year based on a license agreement with Memorial Sloan Kettering Cancer Center to create a de-identified digital pathology dataset. The dataset would aid Page.AI to develop its portfolio of AI products across various types of cancer.

The digital pathology startup “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,” said Paige.AI CEO Leo Grady.

FDA, meanwhile, has been working to establish a new regulatory framework to foster innovation and streamline the development of digital health technologies through a pilot known as the Digital Health Software Pre-Certification Program. The pilot will be limited to first-of-its-kind software as a medical device, including AI-powered software solutions. And FDA has sped up its approvals of AI-powered devices during 2018.

Editor's note: A previous version of this story misspelled the name of Paige.AI in the headline. We regret the error.


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