Paige, a global leader in computational pathology, today announced it received Federal Drug Administration (FDA) 510(k) clearance for the FullFocus™, a digital pathology image viewer for the purpose of primary diagnosis. This 510(k) clearance from the FDA allows in vitro diagnostic (IVD) use of FullFocus with FDA-authorized Philips Ultra Fast Scanner and paves the way for IVD use of FullFocus with additional IVD Whole Slide Imaging (WSI) scanners in the future.
Lack of interoperability, intensive capital requirements and burdensome, on-premise storage have 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 intuitively view and navigate digital images of surgical pathology slides acquired on all major commercial brands of WSI scanners. 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 performance requirements for IVD use, with accurate color reproducibility, optimized viewing speeds and adherence to a certified quality management system. Committed to providing a flexible solution for hospitals, Paige is working to expand upon the clearance to incorporate use with additional WSI scanners and monitor displays 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.
“A viewing and storage platform that is interoperable with various existing digital pathology tools could enable pathologists to collaborate with their team, remotely, without sacrificing security and privacy – all essential pieces of ‘going digital’ in pathology,” said Matthew G. Hanna, MD, the Director of Digital Pathology Informatics at MSK.
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.
Dr. Hanna has a compensated consulting relationship with Paige. MSK has intellectual property rights and associated financial interests related to Paige by virtue of licensing agreements between MSK and Paige.
