iCad (NSDQ:ICAD) has won the CE Mark for its advanced artificial intelligence technology and workflow solution, ProFound AI for 2D mammography.
The Nashua, N.H.-based cancer detection and radiation therapy devices maker developed the technology to boost breast cancer detection by identifying soft-tissue densities and calcifications.
ProFound AI for 2D mammography is the latest addition to iCad’s ProFound AI platform, joining ProFound AI for Digital Breast Tomosynthesis (DBT), which was CE Marked in March 2018, FDA-cleared in December 2018, and Health Canada-licensed in July 2018.
“Europe contains 9% of the world’s population but has more than 23% of the global cancer burden, with breast cancer being the most common cancer among European women,” said iCad president Stacey Stevens in a news release, citing a 2018 worldwide cancer study and a United Nations population study. “This CE Mark further validates our ProFound AI platform as a world-class artificial intelligence solution that offers benefits to both radiologists and screening-aged women in detecting breast cancer. iCAD is committed to improving patient care worldwide and we are pleased to offer this powerful technology to a growing number of hospitals, imaging centers and women across Europe.”
“ProFound AI for 2D Mammography has the potential to assist radiologists in their interpretation of 2D mammography images, as we have seen with ProFound AI for DBT,” said Dr. Axel Gräwingholt of Radiologie am Theater, in Paderborn, Germany. “As breast cancer rates continue to rise, it is imperative for radiologists to find cancers sooner, when they may be more easily treated, with fewer callbacks and false positives, which can be inconvenient and stressful for patients.”