QT Imaging Receives Saudi Approval for Radiation-Free Breast Acoustic CT Scanner
QT Imaging announced that its Breast Acoustic CT scanner has received official classification and clearance from the Saudi Food and Drug Authority (SFDA) for use as a medical device in the Kingdom of Saudi Arabia. This approval enables the company to market, sell, and deploy its radiation-free, compression-free 3D breast imaging technology throughout one of the largest healthcare markets in the Middle East.
In August 2025, QT Imaging entered into an exclusive distribution agreement with Gulf Medical, 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. Breast cancer remains the most commonly diagnosed cancer among women in the Kingdom, creating increasing demand for advanced, patient-friendly imaging technologies that improve access to screening and diagnostic services.
Satrajit Misra, Chief Commercial Officer of QT Imaging, stated that Saudi Arabia represents one of the most attractive healthcare markets in the region, and that the approval enables commercial deployment with Gulf Medical while expanding access to radiation-free, compression-free 3D breast imaging technology for women throughout the Kingdom. He added that 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. 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.
