Paige, New York, has received FDA 510(k) clearance for the FullFocus, a digital pathology image viewer for the purpose of primary diagnosis. This clearance 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. 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. 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,” says 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 with healthcare organizations across the United States, Europe, and Brazil. For additional information, visit Paige. Featured image: FullFocus digital pathology image viewer (Credit: Paige)