QT Imaging Receives FDA Clearance for Its Breast Acoustic CT Scanner Enhanced Configuration to Improve Posterior Breast Imaging Coverage
QT Imaging Holdings, Inc. a medical device company dedicated to transforming breast health management through innovative, radiation-free imaging technology, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for an updated configuration of its Breast Acoustic CT™ scanner, the Company’s 3D ultrasound tomographic breast imaging system. The newly cleared enhanced configuration improves visualization and expands coverage of posterior breast tissue.
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, PhD, 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 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.
About QT Imaging
QT Imaging Holdings, Inc. is a medical device company engaged in the research, development, and commercialization of innovative imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience.
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