FDA clears latest version of Transpara breast AI software

ScreenPoiont Medical has received clearance from the U.S. Food and Drug Administration (FDA) for the latest version of its Transpara AI software for detecting breast cancer.

Transpara version 2.1 has been updated based on additional training and insights from users around the world, the company said. Specifically, Transpara 2.1 is now compatible with options for breast density (BIRADS and volumetric) and temporal comparison, which allows suspicious areas on a current imaging study to be analyzed against up to three priors over six years. This temporal comparison capability is the first of its kind in the market, according to the vendor.

ScreenPoint announced the clearance on December 2 at RSNA in Chicago and noted that several studies at the meeting will present evidence on the clinical and workflow benefits of Transpara 2.1.

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