Paige

Paige became the first company to receive US Food and Drug Administration authorisation for an artificial intelligence-based product in pathology, a landmark that placed it at the centre of the digital pathology and computational oncology sector. Founded in 2017 and headquartered in New York, United States, the company emerged from a long-standing collaboration with Memorial Sloan Kettering Cancer Center, drawing on one of the largest annotated pathology datasets in existence to train its deep-learning models.

Paige Prostate and the FDA Clearance Milestone

The company's first cleared product, Paige Prostate, assists pathologists in detecting prostate cancer on digitised whole-slide images, flagging cases that warrant closer review and reducing the rate of missed diagnoses. This clearance, granted in 2021, opened the regulatory pathway for AI-assisted computational pathology in the United States and established Paige as the benchmark against which subsequent market entrants are measured. The company has continued to expand its portfolio of AI-powered detection and grading tools across multiple cancer types.

Enterprise Pathology Platform and Global Expansion

Beyond individual diagnostic aids, Paige offers an enterprise-grade digital pathology platform that integrates with laboratory information systems and whole-slide image scanners from major hardware vendors. The platform is designed to sit within existing clinical workflows, enabling pathology departments to deploy AI models at scale without wholesale infrastructure replacement. Paige serves academic medical centres, hospital networks, and pharmaceutical research organisations seeking to accelerate tissue-based biomarker analysis in oncology drug development.

The company operates across North America and Europe, with regulatory clearances and CE marking supporting clinical deployment in multiple jurisdictions. Its work in the pharmaceutical and life-science research segment positions it at the intersection of clinical diagnostics and oncology drug development, supporting biomarker discovery and clinical trial endpoint analysis through computational methods applied to pathology data.

Further information is available at paige.ai.