AI-aided pathology company Paige today announced it received FDA clearance for its FullFocus digital pathology image viewer for the purpose of primary diagnosis.
This clearance allows in vitro diagnostic (IVD) use of FullFocus with the FDA-authorized Philips Ultra Fast Scanner and paves the way for IVD use of FullFocus with additional IVD whole slide imaging (WSI) scanners, according to the New York-based company.
The foundation for the FullFocus viewer was created and validated at Memorial Sloan Kettering Cancer Center (MSK) to allow researchers and pathologists to 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 a…