The US Food and Drug Administration (FDA) has sent an approvable letter for U-Systems' somo v automated breast ultrasound (ABUS) system pre-market approval (PMA) application.
The somo v ABUS system utilizes the company’s proprietary technology to automate the ultrasound imaging process and to screen breast cancer.
U-Systems president and CEO Ron Ho said the somo v ABUS system has the potential to find some 30% additional cancers that would not have been found with mammography.
"We are pleased that our development efforts, now supported by the FDA’s scientific review of our safety and clinical data, are bringing us close to final PMA approval," Ho added.
"With this response from the FDA, we will begin preparing for the launch of the somo-v ABUS system across the U.S."
The company plans to work closely with the FDA to complete the final inspection as the system’s PMA application remains subject to satisfactory review.