News|Articles|March 12, 2026

FDA Clears Updated Breast Acoustic CT Scanner with Improved Posterior Breast Imaging Capability

Author(s)Jeff Hall

Providing 3D ultrasound tomographic views, the Breast Acoustic CT device has an updated configuration that reportedly improves coverage and visualization of posterior breast tissue.

The Food and Drug Administration (FDA) has issued a 510(k) clearance for a new configuration of the Breast Acoustic CT device that reportedly facilitates improved coverage of posterior breast tissue with its 3D ultrasound tomographic technology.

Noting the challenges with imaging of posterior breast tissue, Bilal Malik, Ph.D., said the updated configuration of the Breast Acoustic CT (QT Imaging) device features a titled transmitter geometry, which provides enhanced coverage of the breast tissue near the chest wall.

“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,” noted Dr. Malik, the chief science officer of QT Imaging.

Offering reflection mode and transmission mode ultrasound data for the reconstruction of 3D tomographic images, the Breast Acoustic CT device also provides radiologists with quantified fibroglandular tissue volume as well as the fibroglandular tissue to total breast volume (TBV) ratio, according to QT Imaging.


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