QT Imaging’s Breast Acoustic CT scanner has received official classification and clearance in Saudi Arabia for use as a medical device.
The Saudi Food and Drug Authority clearance allows the scanner to be marketed, sold, and deployed throughout Saudi Arabia, according to QT Imaging.
Gulf Medical can now begin commercial activities under an exclusive Saudi distribution agreement signed with QT Imaging in August 2025.
The August agreement made Gulf Medical the exclusive distributor of QTI Breast Acoustic CT scanners and user subscriptions to the QTI Cloud Platform in Saudi Arabia.
The agreement included minimum order quantities of 5 scanners per quarter, starting in Q1 2026 through the end of 2028, for a total minimum of 60 scanners and more than $33M in revenue, according to QT Imaging.
Breast Acoustic CT is a 3D ultrasound tomographic breast imaging system that uses low-frequency sound waves. QT Imaging describes the scanner as radiation-free and compression-free.
The company said the Saudi clearance follows regulatory clearance in the United Arab Emirates. QT Imaging said it now has regulatory clearances in the 2 largest healthcare markets in the Gulf region.
The Saudi clearance remains tied to commercial execution. QT Imaging’s forward-looking statement noted risks around the ability to sell and deploy the scanner and generate revenue under existing distributor contracts.
Company:QT Imaging Holdings
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