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Paige’s FullFocus™ Digital Pathology Viewer Receives FDA 510(k) Clearance for Expanded Compatibility

NextEdge Admin

15 Jan 2025

2 min 4 sec

Paige, a leader in AI-driven digital pathology, announced FDA 510(k) clearance for its FullFocus™ digital pathology viewer, now compatible with the Leica Aperio GT 450 DX scanner (SVS/DICOM formats) and the Hamamatsu NanoZoomer S360MD Slide scanner system (NDPI format), supporting a broad range of monitors.

“We are pleased that Paige’s FullFocus™ viewer is now FDA cleared for clinical use with the NanoZoomer S360MD system,” said James Butler, VP of Marketing at Hamamatsu. “This milestone enhances digital pathology integration, accelerating adoption and improving clinical workflows.”

Paige previously secured clearance for the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS), making FullFocus™ one of the most compatible platforms in digital pathology. “This FDA clearance underscores our commitment to delivering clinically validated, high-impact solutions that shape the future of cancer diagnostics,” said Razik Yousfi, CEO and CTO of Paige.

Paige continues to pioneer AI-powered digital pathology, leveraging exclusive access to millions of digitized pathology slides, clinical reports, and genomic data. By integrating diverse factors such as gender, race, and geography, Paige develops cutting-edge AI solutions that redefine cancer detection, diagnosis, and treatment. As the first FDA-approved AI application in pathology, Paige also introduced the first million-slide foundation model for cancer, reinforcing its leadership in precision diagnostics and transforming cancer care.