Summary: Paige’s FullFocus digital pathology image viewer received FDA 510(k) clearance for use with two of its slide scanners.
Key Takeaways:
- Broader Compatibility: FullFocus now supports SVS, DICOM, and NDPI file formats, making it one of the most versatile digital pathology platforms available.
- Industry Collaboration: The clearance highlights collaboration between Paige, Leica, and Hamamatsu to provide seamless integration and improved workflows in pathology labs.
- Regulatory Excellence: Paige’s achievement demonstrates its commitment to delivering clinically validated, regulatory-compliant AI solutions for cancer diagnostics and precision medicine.
Paige, a leader in next-generation AI technology, announced 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 monitors(1).
“We are pleased that Paige’s FullFocus digital slide viewer is now FDA cleared for clinical use with the NanoZoomer S360MD Slide scanner system,” says 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.”
FDA Clearance of Digital Pathology Solutions
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,” says 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.
References:
- 510(k) Device Number: K241273
- 510(k) Device Number: K201005
