Medical device firm Densitas has received the CE Mark from the European Commission and a medical device license from Health Canada for its DM-Density breast density assessment software.
The regulatory clearances allow Densitas to begin sales and installation of the software in Canada and in European countries where the CE Mark is recognized.
DM-Density is Densitas' first commercial product in digital mammography. It is an adjunctive tool that radiologists use when reviewing a woman's mammogram to assess breast density. DM-Density is the first of a series of mammography imaging systems that are currently in various stages of development, Densitas said.
Plans are also underway to secure regulatory clearance for DM-Density in the U.S.