U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across Different Anatomic Sites
Paige PanCancer Detect recognized by FDA as a Breakthrough Device intended to assist pathologists in the detection of cancer across multiple tissue and organ types
NEW YORK-(BUSINESS WIRE)-Paige, a leader in next-generation AI technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Paige PanCancer Detect*, an AI-assisted diagnostic application intended to assist pathologists in the detection of foci that are suspicious for cancer from multiple tissues and organs. This marks the first designation of its kind for an AI-enabled tool capable of identifying both common cancers and rare variants from different anatomic sites.
“The Breakthrough Device designation demonstrates the significance of AI in transforming cancer diagnostics,” said Dr. David Klimstra, Co-Founder and former Chief Medical Officer at Paige. “By aiding in the identification of cases with cancer and flagging potential diagnostic discrepancies, Paige PanCancer Detect can help pathologists focus on the most critical cases and reduce time to diagnosis, leading to faster results for patients.”
The FDA established the Breakthrough Devices Program as a voluntary mechanism for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval and marketing authorization.
“We see this designation as another pivotal step in transforming cancer diagnostics,” said Razik Yousfi, CEO and CTO of Paige. “Paige remains committed to developing AI solutions that not only drive innovation but also meet the highest regulatory standards. This achievement underscores our continued leadership in building clinical applications that establish a new benchmark for regulatory excellence—advancing patient care and shaping the future of pathology.”
The Breakthrough Device designation for Paige PanCancer Detect represents a significant milestone in the company’s mission to advance precision medicine and equip pathologists with the tools they need to meet the evolving demands of cancer diagnostics. Paige PanCancer Detect is available within Paige Alba™, the Paige Platform, and our partner digital pathology platforms.