EU Certifies Software That Assesses Short-term Breast Cancer Risk

ProFound AI Risk, a diagnostic tool that estimates the risk of breast cancer over a two-year period following a mammogram, has received a CE mark from the European Commission.

The CE mark is a certification for products sold in the European Economic Area to indicate the product has met all legal standards, and has been evaluated to meet all safety, health, and environmental regulations.

“The CE Marking 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, which developed the software, in a press release.

The ProFound AI technology utilizes a computer algorithm that incorporates data from a mammogram screening, as well as risk factors such as age and breast density, to predict the risk of breast cancer for individual patients.

As 2D mammograms are the primary method used to screen women for breast cancer in Europe, the ProFound AI Risk software builds upon that to provide short-term risk assessment.

Research has shown that ProFound AI Risk can improve a clinician’s ability to evaluate the short-term risk of breast cancer better than previously utilized models, which tend to focus on five- or 10-year risk estimates.

“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,” Stevens said. “This technology offers more valuable insights for clinicians, compared to other risk models, which offer five or 10 year-risk estimates.”

ProFound AI Risk is the newest breast cancer risk assessment tool developed by iCAD, joining previously released products such as ProFound AI for Digital Breast Tomosynthesis (DBT), ProFound AI for 2D Mammography, and PowerLook Density Assessment.

“We have had outstanding feedback from our European customers on the clinical value that ProFound AI has brought to their practices,” said Michele Debain, vice president of Europe, Middle East, and Africa for iCAD. “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.”

In particular, iCAD noted that the ProFound AI software is effective at analyzing risk in women with dense breast tissue, in which cancer may be more difficult to detect.

“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,” Debain said. “Additionally, it is particularly effective in challenging cases, such as those with dense breast tissue.”

The technology was first revealed at the recent European Congress of Radiology meeting, held virtually this year.

iCAD also presented supporting data at the meeting, including a study entitled “The value of 2D-AI-based CAD for second or third reading tested on 17,910 screening mammograms.”

In the study, researchers performed mammogram screenings on 18,002 patients between January and November 2018, and determined that ProFound AI’s ability to detect cancers was greater than that of two radiologists who read the same cases. The technology demonstrated a sensitivity of 91.5% and a specificity of 80.2% for a total of 117 breast cancers, including 32 ductal carcinoma in situ and 85 invasive cancers.

“Achieved results justify hopes to use novel CAD systems for a second (e.g. in countries with a shortage of readers) or third reading in the near future,” the researchers wrote.

“Human consensus reading remains indispensable,” they added.