SimonMed Imaging, one of the largest outpatient medical imaging providers and largest physician radiology practices in the United States, announced their implementation of the first FDA-cleared AI program for significantly enhancing early breast cancer detection for 3D mammography. The AI program, called ProFound AI™ for digital breast tomosynthesis (DBT), is a technology developed by iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions.

ProFound AI for DBT is a high-performance, deep learning, workflow solution that assists radiologists reading mammography. It is the first and only FDA cleared 3D tomosynthesis technology using artificial intelligence.

“Implementing ProFound AI into our processes for breast cancer screenings will improve detection of breast cancer and reduction of false positives and recalls,” said John Simon, M.D., Founder and CEO of SimonMed. “With the enhanced technology available through 3D mammography, the review of the 84 slices of breast tissue per breast will now be expedited, but does not replace the specialized radiologist.”

ProFound AI for DBT was FDA-cleared in 2018 and offers benefits to both radiologists and patients alike. Designed to detect malignant soft-tissue densities and calcifications, the software provides radiologists with key data, such as Certainty of Findings and Case Scores, which can assist radiologists in making clinical decisions and prioritizing caseloads. The technology has been clinically proven to improve cancer detection rates by 8 percent, reduce unnecessary patient recall rates by 7.2 percent, and slash radiologists’ reading time by 52.7 percent and up to 57.4 percent for dense breast 3D image analysis. 

“It is exciting to see the momentum generated following the FDA clearance of ProFound AI for DBT and the expansion of our marketplace throughout the SimonMed Imaging enterprise,” said Michael Klein, CEO of iCAD. “This important partnership demonstrates the need for innovative, advanced AI platform solutions to assist radiologists in accurately identifying breast cancer sooner, when it may be more easily treated. SimonMed’s unique nationwide enterprise care model also provides a scalable platform and partnership for future collaboration.”  

SimonMed Imaging and its affiliates have been serving local communities throughout the U.S. for over 30 years, with more than 150 convenient locations to accommodate patients. Patients interested in learning more can call or text SimonMed at 1-866-614-8555 to schedule an appointment. For more information about ProFound AI, visit or