RadNet subsidiary DeepHealth has announced expanded U.S. Food and Drug Administration (FDA) 510(k) clearance for SmartMammo Dx, the algorithm contained within its SmartMammo product, to be used with GE HealthCare’s Senograph Pristina mammography systems.
The algorithm was first cleared by the FDA in 2022 for use with Hologic mammography systems. SmartMammo incorporates AI-driven tools designed to offer greater precision to radiologists interpreting digital breast tomosynthesis (DBT) mammograms.
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