RSNA 2018 News
By AuntMinnie.com staff writers
November 26, 2018

Dutch women's imaging software developer ScreenPoint Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Transpara artificial intelligence (AI) software for screening mammography.

The detection and decision-support software is designed to assist radiologists with reading screening mammograms.

The FDA filing was supported by results from a multireader, multicase reader study, in which the software as a support tool was associated with significantly improved detection accuracy of radiologists, and the standalone sensitivity and specificity of Transpara were almost on par with radiologists, according to ScreenPoint.

Transpara also has the CE Mark in Europe for use with mammography and digital breast tomosynthesis.

ScreenPoint is demonstrating Transpara at RSNA 2018 and will also be presenting two studies on its use by radiologists in mammography.

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Last Updated hh 11/26/2018 3:44:09 PM