Paige Adds to Regulatory Portfolio with New FDA Clearance

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510(k) FDA Clearance Received for Two Digital Pathology Scanners: Leica Aperio GT 450 DX and Hamamatsu NanoZoomer S360MD, Further Expanding Paige’s Portfolio

Paige Adds to Regulatory Portfolio with New FDA Clearance

For Media
Cindi Goodsell | Stanton
cgoodsell@stantonprm.com
510-409-3646

Paige, a leader in next-generation AI technology, announced today that its FullFocus™ digital pathology image viewer received FDA 510(k) clearance, for use with the Leica Aperio GT 450 DX scanner (supporting SVS and DICOM file formats) and the Hamamatsu NanoZoomer S360MD Slide scanner system (supporting NDPI file format), with a wide set of monitors1.

“We are pleased that Paige’s FullFocus™ digital slide viewer is now FDA cleared for clinical use with the NanoZoomer S360MD Slide scanner system,” said James Butler, VP of Marketing at Hamamatsu. “This clearance further demonstrates the ongoing effort across the industry to provide pathology labs with seamless integration of best-in-class solutions, helping to accelerate the adoption of digital pathology and drive improved clinical workflows.”

In addition to the Leica Aperio GT 450 DX and Hamamatsu NanoZoomer S360MD Slide scanner system, Paige previously received clearance for use with the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS)2, making FullFocus™ one of the most compatible digital pathology platforms available. This milestone underscores Paige’s continued focus on delivering high-quality, compliant solutions to meet the industry’s evolving needs.

“This FDA clearance highlights our dedication to developing clinically validated, high-impact solutions that enable the future of cancer diagnostics,” said Razik Yousfi, CEO and CTO of Paige. “Our ability to navigate complex regulatory pathways and deliver products that meet stringent regulatory requirements reinforces our position as a trusted leader in building advanced AI and digital pathology technologies.”

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.

1510(k) Device Number: K241273
2510(k) Device Number: K201005

About Paige

Paige is pushing the boundaries of AI to solve cancer’s most critical issues, revolutionizing cancer care with next-generation technology. By leveraging exclusive access to millions of digitized pathology slides, clinical reports, and genomic data, Paige gains a holistic understanding of cancer, encompassing diverse factors such as gender, race, ethnicity, and geographical regions. This comprehensive data enables Paige to create advanced AI solutions that redefine cancer detection, diagnosis, and treatment. With a unique, intricate understanding of tissue, Paige sets new standards in precision diagnostics, earning the distinction of being the first FDA-approved AI application in pathology. Paige has also developed the first million-slide foundation model for cancer, continuing to lead the way in uncovering novel insights and transforming them into life-changing products. For more information, visit www.paige.ai.