iVu Imaging

iVu Imaging is a private U.S. medical device company focused on breast imaging. Its flagship product, SOFIA, is an automated 3D breast ultrasound system designed to provide rapid, compression-free supplemental imaging, particularly for women with dense breast tissue. The company markets SOFIA to radiologists, OB/GYN practices, and primary care settings as a workflow-friendly tool intended to improve earlier breast cancer detection. iVu Imaging received FDA 510(k) clearance for its SOFIA Automated Tomographic Ultrasound system and has pursued commercial distribution partnerships, including with Hitachi Aloka Medical. The business appears to be an active healthcare imaging company rather than a drug-development biotech.