iCAD secures FDA clearance for ProFound Detection 4.0

iCAD has received clearance from the U.S. Food and Drug Administration (FDA) for the latest version of its ProFound Detection software for digital breast tomosynthesis.

ProFound Detection 4.0 was trained using advanced deep-learning convolutional neural networks and achieved a 22% overall improvement over the prior version in detecting some of the most challenging and aggressive cancer subtypes, iCAD said. The new version also delivers more precise lesion marking, with an 18% improvement in cases with no marks, which reduces potential false positives, according to the vendor.

Significantly, ProFound Detection Version 4.0 now enables clinicians to incorporate a prior exam into its AI analysis and case-score/lesion assessment on the current case, which emulates the approach radiologists take when interpreting current screening exams with historical context, iCAD said.