Medical statistics and data mining firm Statlife has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its DenSeeMammo breast density assessment software.
The software provides a standardized and automatic breast density evaluation according to BI-RADS guidelines and can be combined with Statlife's MammoRisk risk assessment tool, the company said. It is compatible with GE Healthcare's Senographe Essential mammography systems, according to Statlife.