FDA clears AI DBT breast cancer detection software from iCAD

ProFound AI™, a cancer detection software system for use with digital breast tomosynthesis (DBT) from iCAD, has received clearance from the U.S. Food and Drug Administration (FDA). The technology is trained to detect malignant soft-tissue densities and calcifications and to help radiologists analyze DBT examinations and determine if a suspicious finding needs additional workup.

 ProFound AI provides radiologists with scoring information representing the likelihood that a detection or case is malignant based on the large dataset of clinical images used to train the algorithm. Scores are represented on a 0% to 100% scale, with a higher score indicating a higher level of confidence in the malignancy of the detection or case. The scores are calibrated to a population of 50% prevalence of cancer and should be interpreted as the probability of the detection or case correctly being identified as malignant in a population of 50% cancers and 50% non-cancers.

iCAD stated that the FDA clearance is based on positive clinical results from a large reader study performed with 24 radiologists who read 260 tomosynthesis cases both with and without iCAD’s ProFound AI solution. For the study, case-level sensitivity improved by 8% on average and specificity increased by 7%. There was a 7% average reduction in recalls and approximately 6% improvement in radiologist AUC.  Reading times also decreased by more than 52% on average, according to the Nashua, NH-headquartered company.

Now available for commercial sale in the United States, ProFound AI is also available in Canada and Europe.