FDA clears Statlife's breast density assessment software

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.

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