NEW YORK ─ Computational pathology firm Paige said on Tuesday that it has received US Food and Drug Administration 510(k) clearance for use of its FullFocus digital pathology image viewer with the Philips Ultra Fast scanner for primary diagnosis.
The clearance paves the way for the in vitro diagnostic use of FullFocus with additional IVD whole slide imaging (WSI) scanners, Paige said.
"The COVID-19 pandemic has made it painfully clear that pathologists need better solutions to work safely and remotely," Paige CEO Leo Grady said in a statement. "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."
The foundation for the FullFocus viewer was initially created and validated at Memorial Sloan Kettering Cancer Center to allow researchers and pathologists to view and navigate digital images of surgical pathology slides acquired on all major commercial brands of whole-slide imaging scanners.
After refinement during 18 months of daily 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, the company said.
New York-based Paige added that it is committed to providing a flexible solution for hospitals and working to expand upon the FDA clearance to incorporate the use of its FullFocus Viewer soon with additional WSI scanners and monitors.
The FullFocus viewer operates within the Paige Platform, which offers managed storage. The combined offering can be quickly deployed in clinical settings, requires minimal upfront costs, and allows for collaboration between geographically distributed pathologists, Paige said.
In 2019, the company announced CE marking for its artificial intelligence-based prostate cancer detection solution and FullFocus.
The FDA granted Breakthrough Device Designation to the company's AI-based pathology tools last year.
Earlier this month, Paige announced it received $15 million in Series B funding from Goldman Sachs' Merchant Banking division, bringing the total funding received from the bank to $20 million.