iCAD reached a significant milestone this week by receiving CE mark for its artificial intelligence (AI) breast cancer detection solution.
The Nashua, NH-based company said ProFound AI for 2-D Mammography is a deep-learning algorithm that analyzes each mammography image and provides insight into each individual case, such as highlighting the most suspicious areas and assigning Certainty of Finding and Case Scores, which can assist radiologists in making clinical decisions and prioritizing caseloads.
"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," Stacey Stevens, president of iCAD, said in a release. "This CE mark further validates our ProFound AI platform as a world-class AI 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 was greenlit by FDA in December of 2018. During a May earnings call, Stevens spoke about how GE Healthcare, another company in the breast cancer detection space could benefit from the technology.
"GE has realized that they can really lead with ProFound AI as the key differentiator for their Tomo system," Stevens said according to a transcript from Seeking Alpha. "We're seeing them get some momentum. We're seeing them really show a desire to take back some share from Hologic and I think you really see that and much more aggressive marketing coming from them. They seem to be making more investments in their field organization, and we are seeing a very strong desire by GE to partner with iCAD at the field level as well.
iCAD has had a long presence in machine learning that occurred long before the AI Renaissance medtech is currently experiencing. The firm has been highly-active and in 2017 it was a finalist for Medtech Company of the Year.