Today, Paige, a leading AI (artificial intelligence) company that is focused on cancer, announced its third FDA recognition—this time its FullFocus™ digital pathology image viewer received FDA 510(k) clearance for use with the Leica Aperio GT 450 DX scanner and the Hamamatsu NanoZoomer S360MD slide scanner system.
This clearance marks a significant advancement in the global cancer digital pathology industry, which will have an enormously positive impact on patients
This clearance marks a significant advancement in the global cancer digital pathology industry that will have an enormously positive impact on patients.
Why does this matter in healthcare?
- Improved Accuracy and Efficiency: This clearance provides pathology labs with seamless integration of best-in-class solutions to accelerate the adoption of digital pathology and improve clinical workflows.
- Accelerated Digital Pathology Adoption: Paige’s technology in digital pathology settings will help improve the speed of cancer diagnosis and lead to better patient outcomes.
- AI’s Role in Healthcare: It underscores the growing impact of AI in advancing cancer diagnostics through regulatory-approved innovations.
Paige is a company focused on using artificial intelligence to revolutionize cancer diagnosis and treatment by developing advanced software that assists pathologists in making faster and more accurate cancer diagnosis through digital pathology, primarily utilizing large image-based AI models to analyze tissue samples.

Paige is considered a leader in the field of clinical AI applications in pathology, even receiving FDA approval for some of their AI tools.
Razik Yousfi, the company’s CEO and CTO, told Breaking Cancer News today, “The FDA clearance highlights our dedication to developing clinically validated, high-impact solutions that enable the future of cancer diagnostics.
“Paige remains committed to developing innovative digital pathology solutions that support precision medicine and enhance clinical workflows by combining advanced technology with regulatory-grade reliability.”