GE Healthcare (NYSE:GE) is hoping to extend FDA premarket approval for its Senographe Essential system to adds on 3D breast imaging, or tomosynthesis, to the device’s approved indications.
The technology giant sent its application into the federal watchdog agency for review based on results of a study showing that Senographe digital breast tomosynthesis is on par with full-field digital imaging in detecting breast cancer.
GE calls the Senographe Essential its "flagship" digital mammography system, and the company designed the tomosynthesis option as an add-on for the 1,700 systems currently in U.S. care centers.
"In particular within the Women’s Health business, we aim to help clinicians expand care to more women globally in order to help reduce breast cancer," women’s health general manager Prahlad Singh said in prepared remarks.
