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… Continue reading.