FDA Clears Transpara 3D for Clinical Use

Transpara 1.6.0, from Netherlands-based ScreenPoint Medical, is the first artificial intelligence solution for detecting breast cancer in both 2D and 3D mammography cleared for use in the United States.

In order to obtain FDA clearance, the company performed a clinical reader study which demonstrated that accuracy of radiologists significantly improved when reading 3D mammograms with support from Transpara. In addition, 3D reading time was significantly reduced to about 35 seconds per exam, bringing it close to 2D reading efficiency.

“We are delighted that the U.S. FDA has cleared Transpara 1.6.0 to be marketed in the USA. This is a major breakthrough from ScreenPoint Medical and it means that our new and existing US customers now have access to the power of Transpara 3D for the first time,” says CEO Nico Karssemeijer. “Multiple independent peer reviewed publications have already demonstrated that Transpara significantly improves accuracy in 2D mammography, now the same applies for 3D.”

“We also understand that reading 3D mammography presents radiologists with huge workload challenges. With feedback from the field, we redesigned the Transpara 1.6.0 interface and utilised our patented co-registration slice technology to optimize reading workflow with advanced navigation support to significantly reduce reading times.”