FDA Clears QT Imaging’s Updated Breast Acoustic CT Scanner

QT Imaging Holdings Inc. has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for an updated configuration of the Breast Acoustic CT scanner, its 3D ultrasound tomographic breast imaging system. The newly cleared enhanced configuration improves visualization and expands posterior breast tissue coverage.

“The updated configuration cleared by the FDA incorporates a tilted transmitter geometry that improves tomographic imaging coverage of breast tissue located near the chest wall, which is an area that can be extremely challenging to capture,” QT Imaging Chief Science Officer Bilal Malik, Ph.D., said. “This design delivers more complete coverage and improved overall diagnostic utility by optimizing the scanner’s ability to include posterior breast tissue that is often difficult to image with standard approaches. We remain dedicated to developing and refining technologies that provide greater precision and confidence to deliver the best outcomes for women regardless of breast density.”

The QTI Breast Acoustic CT scanner generates both reflection-mode and transmission-mode ultrasound data to reconstruct 3D tomographic images. Its proprietary software quantifies fibroglandular tissue volume (FGV) and the ratio of fibroglandular tissue to total breast volume (TBV), providing valuable insight for breast health assessment and monitoring.

QT Imaging Holdings Inc. is a medical device company engaged in the research, development, and commercialization of imaging systems using low-frequency sound waves. Its strategy is based on the fact that medical imaging is critical to disease detection, diagnosis, and treatment, and that it should be safe, affordable, accessible, and centered on the patient’s experience. Breast Acoustic CT is a trademark of a QT Imaging Holdings affiliate.