Breast Density Assessment Software Receives FDA Clearance

The US Food and Drug Administration (FDA) has given 510(k) clearance to a machine learning breast density assessment software that empowers radiologists with standardized, personalized and automated density reports to optimize women’s breast health and follow-up care decisions. The software is now cleared for clinical use in the US, Europe, Canada and Australia, and is the first of several follow-on products to be launched by Densitas Inc., (Nova Scotia, Canada), a developer of breast imaging analytics.

Densitas develops advanced imaging analytics technologies powered by machine learning that deliver actionable insights at point-of-care for personalized breast health. The company’s products address the key challenges currently facing breast imaging, such as mammography quality, workflow efficiencies, compliance with national guidelines and standards, and delivery of appropriate care at sustainable costs.

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.

“Receiving 510(k) clearance marks a significant milestone in our company’s growth as we expand our global reach into the US market with our flagship product,” said Mohamed 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.”

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