FDA grants tech startup Breakthrough designation for use of AI in cancer research

The FDA on March 7 granted Breakthrough Device designation to Paige.AI, a year-old New York startup that’s using AI to help diagnose and treat cancer, the company announced.

Paige.AI, launched in early 2018, is based on technology developed by Thomas Fuchs, a physician and co-founder of the company, and partners at the Memorial Sloan Kettering Cancer Center in New York, according to a press release. MSK started digitizing its pathology slides four years ago, and through a licensing agreement with the hospital Fuchs’ team works with resulting de-identified datasets to develop a portfolio of AI products “to serve the needs of pathologists around the world.”

MSK has digitized more than a million archive slides to date, and Paige.AI is funding the digitization of another four million.

“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 AI in computational pathology to combine vast amounts of high-quality data with unique deep learning architectures in service of delivering better patient care,” Fuchs said in the release.

The FDA’s Breakthrough Device designation is granted for technologies that have the potential to transform the diagnosis, treatment and clinical care of life-threatening or irreversibly debilitating diseases, but have no competitors or outperform existing tech already on the market.

Paige.AI is the first company to ever receive the Breakthrough designation for technology that leverages AI for cancer diagnosis.

“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,” Leo Grady, CEO of the company, said in the 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.”