Densitas Secures 510(k) Clearance
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.
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