Densitas, a medical device company based out of Halifax, Nova Scotia, Canada, announced that DENSITAS|density, its software that uses machine learning to produce breast density reports, has gained FDA clearance.
“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,” Mohamed Abdolell, CEO of Densitas, said in a prepared statement. “Our market entry 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.”
The software interprets digital mammography and automatically produces a breast density report. According to Densitas, the reports “are as accurate as the visual assessments made by experienced MQSA-qualified radiologists.”
The software had already been cleared in Europe, Canada and Australia.