Saudi Arabian Regulators Clear QT Imaging’s Breast Acoustic CT Scanner

QT Imaging Holdings Inc.’s Breast Acoustic CT scanner has received official classification and clearance from the Kingdom of Saudi Arabia (KSA) for use as a medical device.

The Saudi Food and Drug Authority (SFDA) approval allows QT Imaging’s Breast Acoustic CT scanner to be marketed, sold, and deployed throughout country, 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.

“Receiving SFDA approval is a major achievement for QT Imaging and an important step in our global commercialization strategy,” QT Imaging Chief Commercial Officer Satrajit Misra said. “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.”

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.

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.

QT Imaging Holdings Inc. is a medical device company researching, developing, and commercializing imaging systems using low-frequency sound waves. Its strategy is predicated upon the fact that medical imaging is critical to disease detection, diagnosis, and treatment, and that it should be safe, affordable, accessible, and centered on the patient’s experience.

References
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