The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to ScreenPoint Medical for its Transpara 1.6.0 artificial intelligence (AI) clinical decision-support system for 2D mammography and 3D mammography, also known as digital breast tomosynthesis (DBT).
Transpara 1.6.0 is designed to facilitate the radiology reading workflow for 2D mammography and DBT using AI algorithms. A clinical reader study performed by the company demonstrated that Transpara 1.6.0 improved radiologists' accuracy for reading DBT exams and reduced DBT reading time to about 35 seconds per exam -- nearly the same amount of time required to read a 2D mammogram.
ScreenPoint previously received FDA clearance for the use of Transpara with screening mammography. With the latest clearance, U.S. customers can now use Transpara to assist reading 2D mammography and DBT.