Paige, a specialist in computational pathology, has announced it has received FDA 510(k) clearance for the FullFocus™ viewer for primary diagnosis of digital pathology slides. While the FullFocus viewer intuitively allows pathologists to view and navigate images from all major commercial brands of scanners, this clearance initially applies to FullFocus when used together with the Philips Ultra Fast scanner.
Lack of interoperability, intensive capital requirements and burdensome, on-premise storage has long been a challenge in the adoption of digital pathology. The foundation for the FullFocus viewer was initially created and validated at Memorial Sloan Kettering Cancer Center (MSK) to allow researchers and pathologists to view any digital image regardless of the scanning platform used to generate the image. After refinement based on 18 months of daily use for retrospective slide review by dozens of practicing pathologists at MSK, the viewer was further enhanced by Paige to meet the system requirements for primary diagnosis, with optimized viewing speeds and adherence to a certified quality management system. In order to provide a flexible solution for hospitals, Paige is working to expand upon the clearance to incorporate use with additional scanners and monitors in the near future.
“The COVID-19 pandemic has made it painfully clear that pathologists need better solutions to work safely and remotely,” said Leo Grady, PhD CEO at Paige. “Pathology labs, hospitals and biopharma companies need to serve patients and conduct research with little disruption, without having to be physically present at their labs. Receiving FDA clearance for the FullFocus viewer allows Paige to further its commitment to modernizing workflows for pathologists so that they can manage their ever-increasing workloads in an efficient, organized, collaborative and secure way and ultimately help patients get the right care at the right time.”
The FullFocus viewer operates within the Paige Platform, which also offers fully-managed, cost-effective storage capabilities. The combined offering can be quickly deployed in any clinical setting, requires minimal upfront costs and allows for collaboration between geographically distributed pathologists, streamlining the path to digital pathology. The Paige Platform is also designed to deliver best-in-class computational pathology products.
In November 2019, FullFocus received the CE Mark, opening its use to European pathology practices. Paige has early access trials across the United States, Europe and Brazil, with healthcare organizations interested in better serving patients and maintaining business continuity.