ScreenPoint Medical used the venue of the RSNA 2018 annual meeting to announce that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Transpara™ detection and decision support software, designed to assist radiologists with the reading of screening mammograms.
Transpara automatically identifies soft-tissue and calcification lesions and combines the findings of all available views into a single cancer suspiciousness score. Interactive decision support is also provided to improve assessment of lesions and is provided concurrent during reading.
The company, headquartered in Nijmegen, The Netherlands, said that Transpara is the first artificial intelligence (AI) application designed to detect breast cancer in screening mammograms to receive FDA clearance. The product has already received European regulatory CE Mark approval for use with mammography and also digital breast tomosynthesis.
Screenpoint stated that the FDA clearance was supported by the results of a multireader, multicase reader study which compared breast cancer detection performance of breast radiologists reading 240 mammograms unaided with performance supported by an AI system.1
ScreenPoint Medical receives FDA clearance for screening mammography AI software. Appl Radiol.