QT Imaging Receives Saudi Arabia FDA Regulatory Clearance
Allows for Commercial Deployment of the Company’s Radiation-Free Breast Imaging Technology Under Distribution Agreement with Gulf Medical Co.
NOVATO, Calif.–(BUSINESS WIRE)–
QT Imaging Holdings, Inc. (Nasdaq: QTI) (“QT Imaging” or the “Company”), a medical device company dedicated to transforming breast health management through innovative, radiation-free imaging technology, today 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.
In August 2025, QT Imaging entered into an exclusive distribution agreement with Gulf Medical Co., a leading provider of healthcare technologies in Saudi Arabia. With SFDA approval now secured, Gulf Medical is positioned to begin commercial activities and engage healthcare institutions throughout the Kingdom.
Saudi Arabia continues to invest heavily in healthcare modernization and women’s health initiatives as part of Vision 2030 and its Health Sector Transformation Program, which aims to improve healthcare access, quality, preventive care, and digital health infrastructure across the Kingdom.(1) Breast cancer remains the most commonly diagnosed cancer among women in the Kingdom,(2) creating an increasing demand for advanced, patient friendly imaging technologies that improve access to screening and diagnostic services.
“Receiving SFDA approval is a major achievement for QT Imaging and an important step in our global commercialization strategy,” said Satrajit Misra, Chief Commercial Officer of QT Imaging. “Saudi Arabia represents one of the most attractive healthcare markets in the region. This approval enables us to begin commercial deployment with our partner Gulf Medical and expands access to our radiation free, compression free 3D breast imaging technology for women throughout the Kingdom.”
“The approval further demonstrates QT Imaging’s ability to successfully navigate international regulatory pathways and positions the Company for continued growth across the Middle East and other global markets,” added Misra.
With regulatory clearances now secured in both Saudi Arabia and the United Arab Emirates, QT Imaging has established a commercial foundation in the two largest healthcare markets in the Gulf region.
About QT Imaging
QT Imaging Holdings, Inc. (Nasdaq: QTI) 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. For more information on QT Imaging Holdings, Inc., please visit the Company’s website at www.qtimaging.com and follow us on LinkedIn.
Breast Acoustic CT™ is a trademark of an affiliate of QT Imaging Holdings, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the QT Imaging Breast Acoustic CT Scanner, including its commercialization in the UAE and Saudi Arabia, manufacturing (including large scale) and further development, advanced image reconstruction software performance of software enhancements, plans for QT Imaging, new product development and introduction, product sales growth and projected revenues, QT Imaging’s industry, future events, and other statements that are not historical facts. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of QT Imaging’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by you or any other investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control. These forward-looking statements are subject to a number of risks and uncertainties, including those relating to: the ability of the Company to sell and deploy the QT Imaging Breast Acoustic CT™ Scanner; the ability to extend product offerings into new areas or products; the ability to commercialize technology; unexpected occurrences that deter the full documentation and “bring to market” plan for products; trends and fluctuations in the industry; changes in demand and purchasing volume of customers; unpredictability of suppliers; the ability to attract and retain qualified personnel and the ability to move product sales to production levels; changes in domestic and foreign business, market, financial, political, and legal conditions; the uncertainty of projected financial information; delays caused by factors outside of our control; changes in our ability to successfully receive purchase orders and generate revenue under our existing contracts with partners and distributors; our ability to realize the benefits of the strategic partnerships; the identified material weakness in our internal controls over financial reporting (including the timeline to remediate the material weakness); the rollout of the business and the timing of expected business milestones; the effects of competition on our future business; our ability to obtain and access financing in the future; our ability to pay our debt obligations as they come due; and those factors discussed in the Company’s reports and other documents filed with the SEC, including under the heading “Risk Factors.” If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that QT Imaging presently does not know or that QT Imaging currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect QT Imaging’s expectations, plans or forecasts of future events and views as of the date of this release. QT Imaging anticipates that subsequent events and developments will cause QT Imaging’s assessments to change. However, while QT Imaging may elect to update these forward-looking statements at some point in the future, QT Imaging specifically disclaims any obligation to do so. Accordingly, undue reliance should not be placed upon the forward-looking statements.
(1) Saudi Vision 2030, Health Sector Transformation Program https://www.vision2030.gov.sa/en/explore/programs/health-sector-transformation-program. Accessed June 2026.
(2) Global Cancer Observatory (GLOBOCAN 2022), International Agency for Research on Cancer (IARC), World Health Organization. Saudi Arabia Fact Sheet: https://gco.iarc.who.int
View source version on businesswire.com: https://www.businesswire.com/news/home/20260603313171/en/
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Jody Cain
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KEYWORDS: United States Saudi Arabia North America Middle East California
INDUSTRY KEYWORDS: Women Radiology Biotechnology Oncology Health Medical Devices Health Technology Consumer
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