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 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,” said Paige CEO Leo Grady in a news release. “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.”
FullFocus received the CE Mark in November 2019. Paige announced last week that it received an additional $15 million from Goldman Sachs, bringing its Series B funding round to $70 million.