Densitas Receives 510(k) Clearance for Breast Density SoftwareMar 1, 2018
510(k) clearance of Densitas’ advanced machine learning algorithm empowers radiologists with on-demand actionable information at point-of-care
VIENNA, Austria – March 1 2018 – Breast imaging analytics innovator Densitas® Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its machine learning breast density assessment software. The software empowers radiologists with standardized, personalized and automated density reports to optimize women’s breast health and follow-up care decisions.“Receiving 510(k) clearance marks a significant milestone in our company’s growth as we expand our global reach into the U.S. market with our flagship product,” said Mo Abdolell, CEO of Densitas®. “We are delighted to be entering the largest medical device market in the world, especially as 31 states have passed mandatory breast density notification laws.”
Breast density has been shown to be strongly associated with cancer risk. Densitas® has the distinct advantage of facilitating breast density assessments of routinely stored standard processed images and their priors because the technology processes the same standard digital mammograms that radiologists view. This provides a practical solution for integrating breast density into risk-based models in population-based screening.The software is cleared for clinical use in the U.S., Europe, Canada and Australia, and is the first of several follow-on products. The software is being showcased at the European Congress of Radiology (ECR 2018), booth 114 at the Austria Center Vienna.
Densitas® develops advanced imaging analytics technologies powered by machine learning that deliver actionable insights at point-of-care for personalized breast health. Our products address the key challenges facing breast imaging today, including mammography quality, workflow efficiencies, compliance with national guidelines and standards, and delivery of appropriate care at sustainable costs.