by
Gus Iversen, Editor in Chief | March 13, 2026
QT Imaging Holdings has received FDA 510(k) clearance for an updated configuration of its Breast Acoustic CT scanner, a 3D ultrasound tomographic imaging system designed for breast imaging.
The change is intended to improve visualization of tissue near the chest wall, an area that can be difficult to capture with conventional approaches.
The Novato, California-based company said the updated configuration modifies the scanner’s transmitter geometry. By tilting the transmitter, the system can capture a wider portion of posterior breast tissue, expanding imaging coverage, compared with earlier configurations.
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Posterior breast tissue, located close to the chest wall, can be challenging to visualize with some breast imaging techniques. The revised design aims to improve the completeness of tomographic images in that region.
“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,” said Bilal Malik, Ph.D., chief science officer of QT Imaging. “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 innovative technologies that provide greater precision and confidence to deliver the best outcomes for women regardless of breast density.”
The Breast Acoustic CT system uses low-frequency sound waves to produce 3D images of the breast without ionizing radiation. The scanner collects both reflection-mode and transmission-mode ultrasound data, which are combined to reconstruct tomographic images.
QT Imaging’s software also measures fibroglandular tissue volume and calculates the ratio of fibroglandular tissue to total breast volume. The company says these metrics may support breast health assessment and monitoring.
QT Imaging develops imaging technologies based on low-frequency acoustic signals. The company focuses on breast imaging systems intended to improve access to radiation-free diagnostic tools and to support detection and monitoring of breast disease.
