Quibim has received clearance from the U.S. Food and Drug Administration (FDA) for the use of its QP-Prostate MRI software to help detect and diagnose prostate cancer.
The software’s clearance as a CADe/CADx device follows a validation study led by researchers at Mass General Brigham in Boston that met a superiority endpoint of aided radiological performance versus unaided performance, as well as its primary endpoint of area under the receiving operating curve (AUROC) using biopsy as ground truth, the company said.
Quibim, based in Valencia, Spain, noted that it recently closed on $50 million in financing to support strategic collaborations with U.S. hospitals and pharmaceutical companies and that QP-Prostate was initially cleared in 2021 for automated segmentation of prostate regions.