iCAD Announces FDA Clearance for ProFound AI Version 3.0 for 3D Mammography

Company’s third generation AI solution offers significant improvement in algorithm specificity performance and faster processing compared to previous versions of the software

Deep learning technology builds upon iCAD’s established leadership in mammography AI

NASHUA, N.H., March 15, 2021 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that ProFound AI Version 3.0 for Digital Breast Tomosynthesis (DBT) was cleared by the U.S. Food and Drug Administration (FDA). Compared to previous versions of the software, the ProFound AI 3.0 algorithm offers up to a 10% improvement in specificity performance and up to 1% improvement in sensitivity.¹ ProFound AI Version 3.0 also offers up to 40% faster processing on the new PowerLook platform.¹

“The FDA Clearance of ProFound AI Version 3.0 is yet another milestone that positions iCAD and our technology as vanguards in the cancer detection realm. Our third generation AI solution for DBT may afford physicians the ability to interpret an increasing amount of data in DBT cases and analyze each image to detect malignant lesions more efficiently and with even greater precision,” said Michael Klein, Chairman and CEO of iCAD. “Improvements in specificity, which correlates with reductions in false positives, typically come at the expense of sensitivity and cancer detection scores. To increase sensitivity while simultaneously improving specificity is a huge performance achievement.”

ProFound AI for DBT is a high-performance, deep-learning, workflow solution trained to detect malignant soft tissue densities and calcifications. It became the first 3D tomosynthesis software using artificial intelligence (AI) to be FDA cleared in December 2018.

Built with the latest in deep-learning technology, ProFound AI for DBT rapidly analyzes each tomosynthesis image, detecting malignant soft tissue densities. Certainty of Finding and Case Scores are relative scores computed by the ProFound AI algorithm and represent its confidence that a detection or case is malignant. The Certainty of Finding scores help radiologists by aiding in clinical decision making. Case Scores, which are assigned to each case by the algorithm, help clinicians to gain a sense of case complexity, which may be useful for prioritizing the reading work list.