FDA gives a green light to cancer diagnosis AI

Big news for digital diagnosis: a company called Paige.AI offers software that scans biopsied prostate tissue for cancerous cells. Launched in 2018, the company has previously worked with Memorial Sloan Kettering Cancer Center— the only healthcare AI company with access to patient tissue slides from the cancer treatment and research institution.

The FDA announced De Novo clearance, which is an alternate pathway for novel, low- or moderate-risk medical devices. The technology has already received a CE mark in the European Union. This clearance is big news for healthcare AI.

While a final patient diagnosis may be based on multiple biopsies and other exam information, the AI program did help improve overall cancer detection by an average of 7.3%. The software also helped cut down the number of false-negative diagnoses by 70% and false positives by 24%.

Fierce BioTech