Densitas Inc., based in Halifax, Nova Scotia, has received FDA clearance for DENSITAS|density, automated breast density software that analyzes the same processed digital mammograms that radiologists view and are routinely stored in PACS.
The zero-click software provides radiologists with breast density assessments at the point of care that are as accurate as the visual assessments made by experienced MQSA-qualified radiologists. The automated reports enhance confidence in follow up care decisions and facilitate uniformity in density measurements across clinics and major hospital networks. DENSITAS|density integrates seamlessly with PACS and enhances workflow.
“Receiving FDA 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,” says Mohamed Abdolell, CEO of Densitas. “Our entry into the US market is timely given the recent recommendations by the American College of Radiology that breast MRI be provided to women with family history of breast cancer and dense breasts, and breast ultrasound to women with dense breasts alone due to the associated risk of cancer.”
Densitas generates breast density assessments from standard processed images and their priors that are stored in PACS. This provides a practical solution for integrating breast density into risk-based models in population-based screening.
“We are delighted to be entering the largest medical device market in the world, especially as 35 States have now passed mandatory breast density notification laws covering over 80% of screen eligible women,” says Abdolell. “Our software radically simplifies compliance with breast density reporting laws and guidelines.”
DENSITAS|density is cleared for clinical use in the United States, Europe, Canada, and Australia.