QTI News & Events

QT Imaging announced the successful completion of its first routine inspection by the FDA, with zero Form 483 observations. The FDA inspection reviewed QT Imaging's Quality Management System and related processes that support the company's operations, with no Form 483 observations issued. The inspector also provided positive feedback regarding the organization of QT Imaging's QMS and the company's responsiveness throughout the inspection process. An FDA Form 483 is issued at the conclusion of an inspection when an FDA investigator has observed conditions that may constitute violations of the Food, Drug and Cosmetic Act and related regulations.

QT Imaging reported the characterization of repeatability and reproducibility metrics for quantitative biomarkers generated by its QT Imaging Breast Acoustic CTTM Scanner platform. The study demonstrated high reproducibility across multiple QT Imaging biomarkers. Speed of Sound, a fundamental tissue property measured directly by our scanner, achieved variability of less than 1% both within a scanner and across scanners. Volumetric measurements derived from SoS image volumes demonstrated variability of approximately 5% for Total Breast Volume and 12% for the ratio of fibroglandular volume to total breast volume. The repeatability and reproducibility analysis was conducted at two clinical sites, with five patients enrolled per site and each patient scanned five times per site, characterizing both within-scanner and across-scanner measurement variability.

QT Imaging Holdings announced that its Breast Acoustic CT scanner has received official classification and clearance from the Kingdom of Saudi Arabia, KSA, for use as a medical device in that country. The Saudi Food and Drug Authority, SFDA, approval allows QT Imaging's Breast Acoustic CT scanner to be marketed, sold, and deployed throughout Saudi Arabia, one of the largest healthcare markets in the Middle East. The approval marks a significant milestone in the Company's international expansion strategy and further strengthens its growing commercial presence across the Gulf region.