NEW YORK ─ Paige announced Wednesday that the US Food and Drug Administration has granted de novo marketing authorization for Paige Prostate to aid in the primary diagnosis of prostate cancer.
The New York-based developer of pathology software said Paige Prostate is the first artificial intelligence-based pathology product to receive FDA de novo authorization, which enables its use for in vitro diagnostic testing with Paige’s FDA-cleared FullFocus digital pathology viewer.
Paige Prostate is designed to assist pathologists in finding small foci of cancer, enabling them to work efficiently and confidently in their diagnostic process, the firm said.
The FDA de novo authorization "allows pathology laboratories to introduce this diagnostic tool into their clinical workflow to help make [pathologists' evaluations] more accurate, more reproducible, and more efficient, which will allow them to focus their attention on the most critical aspects of establishing the diagnosis," David Klimstra, cofounder and chief medical officer at Paige, said in a statement. He added that the authorization "reflects the rigor with which Paige Prostate has been validated, as the first clinical-grade AI technology to assist pathologists in the interpretation of routinely stained slides."
Last July, Paige announced it received FDA 510(k) clearance for use of its FullFocus digital pathology image viewer with the Philips Ultra Fast scanner for primary diagnosis.
In May this year, the firm announced a collaboration with Quest Diagnostics to leverage Paige's machine learning expertise in pathology diagnostic data to discover biomarkers for cancer and other diseases.