FDA clears iCAD's ProFound AI for digital breast tomosynthesis

The FDA cleared iCAD's ProFound AI, a deep-learning, cancer detection software solution for digital breast tomosynthesis (DBT), the company announced Friday. Stacey Stevens, chief strategy and commercial officer, remarked that the clearance "opens a new and substantial addressable market," adding that "clinical reader study results and comprehensive stand-alone testing have shown unprecedented improvements in both clinical performance and reading efficiency."

The clearance is based on results from a large reader study presented this year at the Radiological Society of North America (RSNA) annual meeting. In the study, 24 radiologists read 260 tomosynthesis cases both with and without ProFound AI. The results showed "increased cancer detection rates, reduced false positive rates and patient recalls, and a significant decrease in interpretation times," the company said.

According to iCAD, the technology is trained to detect malignant soft-tissue densities and calcifications, while providing "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." The company added that the solution improves cancer detection rates by an average of 8 percent, decreases unnecessary patient recall rates by an average of 7 percent and can reduce radiologists' reading time by more than 50 percent on average.

Along with the US, ProFound AI is available for use in Canada and Europe.

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