Announcement
ScreenPoint Medical receives FDA clearance for AI application Transpara™ to assist radiologists with reading screening mammograms
26th November 2018
ScreenPoint Medical receives FDA clearance for AI application Transpara™ to assist radiologists with reading screening mammograms
ScreenPoint Medical, a medical imaging company developing artificial intelligence (AI) solutions for the early detection of breast cancer, announced today that it has received 510(k) Clearance from the U.S. Food & Drug Administration (FDA) for Transpara™ detection and decision support software, designed to assist radiologists with the reading of screening mammograms. Transpara is the first AI application for detecting breast cancer in screening mammograms to gain 510(k) Clearance from the FDA, based on its unique functionality which interactively provides support for detection and diagnosis.