FDA grants breakthrough device designation to artificial intelligence technology for cancer diagnosis

The FDA granted breakthrough device designation to Paige.AI, a computational pathology start-up focused on developing artificial intelligence for clinical diagnosis and treatment of cancer.

“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 [patients with cancer],” Leo Grady, PhD, CEO of Paige.AI, said in a company-issued press release. “We are thrilled to receive breakthrough designation and look forward to collaborating with the FDA to bring our products to market, starting with prostate cancer and expanding from there.”

Breakthrough designation is offered to devices or device-led combination products that provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions or diseases. The designation is designed to accelerate development, assessment and review, thereby giving providers and patients timely access to these devices.

“We are honored to have been granted breakthrough designation by the FDA, which underscores the groundbreaking nature of our technology as the leading clinical-grade [artificial intelligence] in computational pathology to combine vast amounts of high-quality data with unique deep learning architectures in service of delivering better patient care,” Thomas Fuchs, Dr.Sc., co-founder of Paige.AI, said in the release.

Paige.AI has a license agreement with Memorial Sloan Kettering Cancer Center, which started to digitize its pathology slides in 2015. The agreement gives Paige.AI access to these slides. The company is funding digitization of another 4 million archive slides, with intentions to use the data set to develop a portfolio of artificial intelligence products for multiple types of cancer.