QT Imaging wins Saudi Arabia approval for radiation-free breast scanner

QT Imaging has received regulatory clearance from Saudi Arabia's Food and Drug Authority to market and sell its radiation-free breast imaging scanner throughout the Kingdom. The approval opens up one of the Middle East's largest healthcare markets for the California-based medical device company.

The clearance allows QT Imaging's distribution partner, Gulf Medical Co., to begin commercial activities with healthcare institutions across Saudi Arabia. QT Imaging signed an exclusive distribution deal with Gulf Medical in August 2025, but needed regulatory approval before sales could begin.

How does it work?

QT Imaging's Breast Acoustic CT scanner uses low-frequency sound waves instead of radiation to create 3D images of breast tissue. The technology offers several patient benefits:

• No radiation exposure during scanning
• No breast compression required
• 3D imaging capabilities for detailed visualization
• Designed to improve patient comfort during screening

The scanner aims to make breast imaging more accessible and patient-friendly while maintaining diagnostic quality. This approach addresses common patient concerns about traditional mammography, including radiation exposure and the discomfort of breast compression.

Why does it matter?

Saudi Arabia has identified women's healthcare as a priority under its Vision 2030 reform program. Breast cancer is the most commonly diagnosed cancer among women in the Kingdom, creating strong demand for advanced screening technologies.

The approval gives QT Imaging access to a significant growth market. Saudi Arabia continues investing heavily in healthcare modernization through its Health Sector Transformation Program, which focuses on improving healthcare access, quality, and digital health infrastructure.

For QT Imaging, this represents a major step in its international expansion. The company now has regulatory clearances in both Saudi Arabia and the United Arab Emirates, establishing a commercial foundation in the Gulf region's two largest healthcare markets.

The context

QT Imaging trades on Nasdaq under the ticker QTI and recently reported first quarter 2026 revenue of $6.5 million. The company has been working to commercialize its acoustic imaging technology and expand into international markets.

The medical imaging industry has seen growing interest in radiation-free alternatives to traditional mammography. Companies are developing various approaches to address patient comfort concerns while maintaining diagnostic accuracy.

"Receiving SFDA approval is a major achievement for QT Imaging and an important step in our global commercialization strategy," said Satrajit Misra, the company's Chief Commercial Officer. "Saudi Arabia represents one of the most attractive healthcare markets in the region."