QT Imaging Holdings, Inc. has received regulatory clearance from the Saudi Food and Drug Authority (SFDA) for its Breast Acoustic CT scanner, allowing the device to be marketed, sold and used in Saudi Arabia.

The approval enables QT Imaging to expand its presence in one of the largest healthcare markets in the Middle East and supports the company’s international growth strategy.

In August 2025, QT Imaging signed an exclusive distribution agreement with Gulf Medical Co.. Following the SFDA clearance, Gulf Medical can begin commercial activities and work with healthcare providers across the Kingdom.

Saudi Arabia is continuing to invest in healthcare modernisation and women’s health programmes through its Vision 2030 and Health Sector Transformation initiatives. Breast cancer remains the most commonly diagnosed cancer among women in the country, increasing the demand for advanced and patient-friendly imaging technologies that support screening and diagnosis.

QT Imaging’s Breast Acoustic CT scanner provides three-dimensional breast imaging without the use of radiation or breast compression. The company believes the technology can improve access to breast health services and enhance the patient experience.

The latest approval follows regulatory clearances already obtained in United Arab Emirates, giving QT Imaging a commercial foothold in the Gulf region’s two largest healthcare markets. The company said the milestone further demonstrates its ability to secure regulatory approvals in international markets and supports its expansion plans across the Middle East and beyond.

 

Source: businesswire.com

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