Densitas launches Canadian-developed technology for breast density assessment
Densitas Inc. today announced it has received the CE Mark from the European Commission and a medical device license from Health Canada for its flagship product, DM-Density. These regulatory clearances allow Densitas to begin sales and installation of its breast density assessment software in Canada and in European countries where the CE Mark is recognized.
DM-Density is Densitas’ first commercial product in the digital mammography enterprise. It is an adjunctive tool that radiologists use when reviewing a woman’s mammogram to assess breast density. Accurately assessing breast density is an important part of the mammography process, as dense breasts have a higher risk of developing breast cancer, and the dense breast tissue makes it challenging to differentiate it from cancer on the X-ray image. DM-Density provides breast density assessment that is automated, precise, standardized, reproducible, and addresses the problem of compliance with breast density reporting, standards and laws.
“It’s exciting to have DM-Density entering markets with such great potential for sales,” said Mohamed Abdolell, CEO of Densitas. “Our products will address the real clinical challenges in the mammography enterprise, focusing on key value pathways that lead to improved care for women.”
Plans are also underway to secure regulatory clearance for DM-Density in the United States.
DM-Density is the first of a series of mammography imaging products that are currently in various stages of development.
Densitas Inc. is an ISO 13485-certified software medical device company. Densitas develops data-driven solutions that address the clinical, administrative and quality requirements of hospitals and radiology clinics and healthcare providers. Densitas’ vision is to be the recognized leader in transforming the untapped massive volumes of data generated in the breast imaging enterprise into actionable information to advance improved clinical outcomes and appropriateness of care. Densitas is focused on providing solutions for personalized breast health care for women and appropriate use of healthcare resources.
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Chicago, Illinois, December 1, 2015