The FDA clears FullFocus™,
a viewer for primary diagnosis of digital pathology images
The intuitive and responsive FullFocus viewer received FDA 510(k) clearance for the purpose of primary diagnosis of digital pathology slides in the U.S. on July 15th, 2020. FullFocus was designed to offer a collaborative and pathologist-centric viewing experience from any CLIA-certified or exempt location*.
*Per CMS guidelines, remote review is possible during the
COVID 19 Public Health Emergency
Connect with Paige to learn more
FullFocus is available for pathology teams in health systems, clinics and laboratories to examine histology slides and sign out from any CLIA-certified or exempt location*.
During the COVID-19 emergency use period, FullFocus can be used with a broad range of monitors and scanners as defined by the FDA on April 24th 2020 and is noted in the guidance aimed at expanding availability of and access to remote viewing and reporting of digital pathology slides.
The Paige Platform
A better way to go digital
FullFocus operates within the Paige Platform, an enterprise imaging solution for digital pathology. The Paige Platform also offers secure, scalable storage and is compatible with existing digital pathology solutions including most scanners, monitors and laboratory information systems (LIS).
A pathologist-centric user experience
Secure, scalable, and highly available storage
Fast performance to load and view digital slides
Cost effective and with no upfront capital expenses
Access to digital slides for multiple users from any internet enabled location*
Fast to deploy and minimal ongoing maintenance needs
Ready to deliver computational pathology products
Designed for interoperability with most scanners, monitors, and LIS
*Per CMS guidelines, remote review is possible during the COVID 19 Public Health Emergency