ICAD's ProFound AI Risk Earns CE Mark in Europe

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Icad has announced that its ProFound AI™ Risk received a CE Mark in Europe. ProFound AI Risk is the first and only clinical decision support tool that provides an accurate two-year, breast cancer risk estimation that is truly personalized for each woman, based only on a screening mammogram. The Company unveiled the technology at the European Congress of Radiology (ECR) virtual meeting from July 15-19, 2020. New data supporting ProFound AI™ will also be presented at the meeting. Information about these products will be available in the virtual iCAD booth (https://ecr2020.expo-ip.com/stand/1115) throughout the meeting.

ProFound AI Risk uniquely combines a range of risk factors, including age, breast density and subtle mammographic features, offering superior performance in assessing short-term risk compared to traditional breast cancer risk models.[ii] It offers an easy-to-implement solution that provides superior insights[iii] that empower clinicians to tailor a woman’s breast screening regimen and potentially identify cancers earlier.

“At last year’s Radiological Society of North America (RSNA) Annual Meeting, we introduced Panorama Powered by ProFound AI, which will enable clinicians to provide more tailored and personalized patient care. With ProFound AI Risk, this concept is coming to life. The CE Mark approval of this technology is a significant milestone that represents the Company’s continued efforts to globally commercialize leading-edge solutions that are positioned to enhance patient care and improve outcomes,” said Stacey Stevens, President of iCAD. “ProFound AI Risk has the potential to address a significant unmet need in breast cancer screening, with an eligible screening population of approximately 250 million women worldwide.[iv] ProFound AI Risk offers a more holistic clinical approach that can provide clinicians with a broader view of each individual patient’s case and two year breast cancer risk, which offers more valuable insights for clinicians, compared to other risk models, which offer five or 10 year-risk estimates. ProFound AI will be available for 2D mammography, which is particularly applicable for the European market, where 2D mammography is still primarily used for breast cancer screening.”

ProFound AI is a deep-learning, artificial intelligence (AI) cancer detection software solution, available for 2D and 3D mammography, or digital breast tomosynthesis (DBT). ProFound AI Risk is the latest addition to iCAD’s suite of breast health solutions, which includes ProFound AI™ for Digital Breast Tomosynthesis (DBT), ProFound AI™ for 2D Mammography, and software solutions for automated breast density assessment.

“We have had outstanding feedback from our European customers on the clinical value that ProFound AI has brought to their practices. Our AI solution is currently being used daily in a growing number of leading hospitals and imaging centers across Europe, and its adoption continues to grow as more doctors and facilities learn of the benefits it offers to both physicians and patients. This powerful software empowers doctors to find breast cancers earlier, when they may be more easily treated, while reducing the rate of false positives, which could lead to fewer unnecessary biopsies or treatments.[v]  Additionally, it is particularly effective in challenging cases, such as those with dense breast tissue,[vi]” said Michele Debain, Vice President, Europe, Middle East, Africa, iCAD.

Positive new data supporting ProFound AI will be presented in several abstracts at the virtual ECR meeting. Of note, the efficacy of ProFound AI for 2D Mammography was validated in a study led by Sylvia H. Heywang-Köbrunner, MD, titled “The value of 2D-AI-based CAD for second or third reading tested on 17,910 screening mammograms” (abstract RPS 702-4). This study examined 18,002 consecutive screening mammograms acquired between January and November 2018, which were anonymized and processed using ProFound AI for 2D Mammography. The AI technology’s ability to detect cancers was superior to that of two radiologists, who read the same cases. ProFound AI for 2D Mammography achieved a sensitivity of 91.5 percent and a specificity of 80.2 percent for 32 ductal carcinoma in situ (DCIS) and 85 invasive cancers. The findings of this study suggest that while AI may not be a replacement for radiologists, it is a valuable tool that can enhance performance and offer better sensitivity than a second reading by radiologists.

“ProFound AI improves my diagnostic confidence. It helps me move faster on negative cases and assists me in discovering positive findings, so that I can focus more time on difficult cases,” according to Dr. Michael Gruber, Radiologist, Radiologische Gruppenpraxis Baden, Austria.

Other relevant abstracts featured during the meeting include:

  • RPS 605b-6: “Breast cancer detection by mammographic view with artificial intelligence in digital breast tomosynthesis,” by Emily F. Conant, MD, professor and chief of breast imaging from the Department of Radiology at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia
  • RPS 602b-1: “Identification of women at high risk of breast cancer and in need of supplementary screening,” by Mikael Eriksson, MD, PhD, Karolinska Institutet


[ii] Brentall A, Harkness E, Astley S et al. Mammographic density adds accuracy to both the Tyrer-Cuzick and Gail breast cancer risk models in a prospective UK screening

cohort. Breast Cancer Res. 2015; 17,147.

[iii] iCAD data on file

[iv] Renub Research (2014) Breast Cancer Screening (Mammography, MRI & Ultrasound) Market & Forecast – Worldwide. http://www.renub.com/breast-cancer-screening-mammography-mri-and-ultrasound-market-and-forecast-worldwide-63-p.php

[v] Conant, E. et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4). Accessed via https://pubs.rsna.org/doi/10.1148/ryai.2019180096

[vi] Hoffmeister, J. (2018). Artificial Intelligence for Digital Breast Tomosynthesis – Reader Study Results. [White paper]. Accessed via https://www.icadmed.com/assets/dmm253-reader-studies-results-rev-a.pdf

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ICAD's ProFound AI Risk Earns CE Mark in Europe.  Appl Radiol. 

By News Release| July 17, 2020

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