Days after it announced it had received regulatory approval in Australia, Halifax-based Densitas Inc. has announced it gained access to the world’s largest medical device market.

The company said Thursday its flagship DM-Density product had received 510(k) clearance from the Food and Drug Administration, which means it can now distribute its software for assessing breast density in the U.S.

The clearance in the U.S. comes after Densitas had already cleared regulatory hurdles in Canada, Europe and (as of last month) Australia. The software is already used in Nova Scotian hospitals and clinics, so any woman who has mammography tests in the province will have her information processed by DM-Density.

“Receiving 510(k) 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,” said Densitas CEO Mohamed Abdolell in a statement. “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.”

Densitas’ technology works by processing images from mammograms to analyze breast density. It is an important factor in the mammography process since dense breasts can easily mask cancerous cells as healthy tissue. Dense breast tissue is also linked to higher chances of breast cancer so if doctors are aware of a patient’s breast density, they can better allocate their time and resources to ensure she gets appropriate care.

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Abdolell, an associate professor in Dalhousie University’s Department of Diagnostic Radiology, has been pushing his idea for a device that measures breast density since 2011. And in all that time he has noted that a growing number of jurisdictions are requiring mammograms to include some assessment of breast density.

The CEO announced the 510(k) clearance while attending the European Congress of Radiology in Vienna. The 510(k) clearance is the basic approval for a medical device in the U.S., and shows the product is safe for use on humans and that it will do what its creators say it will do.

The announcement is the latest in a stream of good news from Densitas. As well as announcing the Australian regulatory approval last month, the company said researchers from the University of Manchester have published a review of breast density measurement methods in the journal Breast Cancer Research. The study clinically validates Densitas’ automated breast density measurement software as a practical solution for use in breast cancer risk models, said a recent statement from the company.

This study demonstrates that while visual and semi-automated density assessments show strong relationships with breast cancer risk, they are not practical for use in population-based screening.

In November, Densitas signed an integration agreement with Cambridge, Massachusetts-based EnvoyAI, an artificial intelligence distribution platform, which is dedicated to incorporating software like DM-Density into healthcare systems. EnvoyAI’s distributor Diagnostic Imaging Australia, will launch DMDensity into the Australian market.

Densitas, whose products use artificial intelligence, noted in its statement Thursday that DM-Density is only its first product, and the company has said that it is planning more releases in the future.