NEW YORK – Paige said on Tuesday that it has secured US Food and Drug Administration 510(k) clearance for the use of the company's FullFocus digital pathology image viewer with scanners from Leica and Hamamatsu.
The FullFocus software is now cleared for use in the US with whole-slide images that are generated from the Leica Aperio GT 450 DX scanner and Hamamatsu NanoZoomer S360MD Slide scanner system. The software was previously cleared for use with images generated with the Philips IntelliSite Pathology Solution Ultra Fast Scanner. Paige also noted that its software is also cleared for use with various monitors.
"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 CEO and Chief Technology Officer Razik Yousfi said in a statement.
James Butler, VP of marketing at Hamamatsu, said that the clearance demonstrates the work within the digital pathology space toward seamless integration of pathology solutions.
Paige said in August that it was shifting its focus toward the development of a testing portfolio that is compatible with various digital pathology platforms rather than limited to the company's own software ecosystem. Yousfi said at the time that the company plans to offer its algorithm-driven tools through other companies' software systems including some that had been competitors to the Paige Platform for slide image management and viewing.