QT Imaging Secures Saudi FDA Approval for Breast Acoustic CT Scanner, Advancing Expansion Across Gulf Healthcare Market
QT Imaging Holdings, Inc., a medical device company focused on transforming breast health management through advanced radiation-free imaging technology, has announced that its Breast Acoustic CT™ scanner has received official classification and regulatory clearance from the Kingdom of Saudi Arabia (KSA). The approval, granted by the Saudi Food and Drug Authority (SFDA), allows the device to be marketed, sold, and deployed across Saudi Arabia, marking a significant milestone in the company’s international commercialization strategy.
The clearance strengthens QT Imaging’s presence in the Middle East and positions the company to participate in one of the region’s most rapidly evolving healthcare markets, where demand for innovative diagnostic technologies continues to grow in parallel with national healthcare modernization initiatives.
A Major Step in QT Imaging’s Global Expansion Strategy
The SFDA approval represents a critical regulatory achievement for QT Imaging as it continues to expand its footprint beyond the United States. With this authorization, the company is now able to introduce its Breast Acoustic CT™ platform to healthcare providers throughout Saudi Arabia, opening access to a new market with substantial growth potential in women’s health and diagnostic imaging.
The Breast Acoustic CT™ scanner is designed as a next-generation breast imaging system that uses acoustic (sound-based) technology rather than ionizing radiation. Unlike traditional mammography, which relies on X-rays and breast compression, QT Imaging’s system provides a radiation-free and compression-free 3D imaging solution. The technology aims to improve patient comfort while maintaining diagnostic accuracy, particularly for women requiring routine breast cancer screening or follow-up evaluations.
With regulatory clearance now secured, QT Imaging is positioned to begin commercial rollout activities in collaboration with its regional distribution partner.
Strategic Partnership with Gulf Medical Co.
In August 2025, QT Imaging entered into an exclusive distribution agreement with Gulf Medical Co., a well-established healthcare technology provider in Saudi Arabia. Gulf Medical has extensive experience supplying medical imaging equipment and healthcare solutions across the Kingdom, making it a strategic partner for local commercialization efforts.
Following SFDA approval, Gulf Medical is expected to initiate commercial deployment activities, including engagement with hospitals, diagnostic imaging centers, and healthcare institutions across Saudi Arabia. This collaboration will play a central role in introducing Breast Acoustic CT™ technology to clinicians and healthcare providers within the region.
The partnership is also expected to support training, installation, and integration of the imaging system into existing diagnostic workflows, ensuring smooth adoption across healthcare facilities.
Supporting Saudi Arabia’s Healthcare Transformation Agenda
Saudi Arabia represents one of the largest and most strategically important healthcare markets in the Middle East. The country has been undergoing a major transformation under Vision 2030, a national development program designed to diversify the economy and modernize key sectors, including healthcare.
A key component of this transformation is the Health Sector Transformation Program, which focuses on improving healthcare access, quality, efficiency, and preventive care while expanding digital health infrastructure across the Kingdom.
Within this framework, women’s health has become an increasingly important area of focus, particularly breast cancer screening and early detection. Breast cancer is currently the most commonly diagnosed cancer among women in Saudi Arabia, creating a growing need for advanced diagnostic tools that can improve early detection rates and patient outcomes.
QT Imaging’s Breast Acoustic CT™ system aligns with these national priorities by offering a non-invasive imaging alternative designed to enhance patient comfort and accessibility while supporting earlier and more effective diagnosis.
Addressing Growing Demand for Advanced Breast Imaging
The introduction of radiation-free, compression-free breast imaging technologies is increasingly relevant in global healthcare systems seeking to improve patient compliance with routine screening programs.
Traditional mammography, while widely used, can be uncomfortable for some patients due to breast compression and may involve exposure to ionizing radiation. These factors can contribute to reduced screening participation in certain populations.
QT Imaging’s Breast Acoustic CT™ technology seeks to address these challenges by using acoustic waves to generate detailed 3D images of breast tissue without radiation exposure. This approach is designed to provide a more comfortable patient experience, potentially improving screening adherence and enabling more consistent monitoring over time.
By expanding access to such technology in Saudi Arabia, QT Imaging aims to support healthcare providers in enhancing early detection capabilities and improving diagnostic pathways for breast health management.
Executive Perspective on Regulatory Milestone
Satrajit Misra, Chief Commercial Officer of QT Imaging, described the SFDA approval as a significant achievement in the company’s global commercialization roadmap.
He emphasized that Saudi Arabia represents a highly attractive healthcare market due to its size, ongoing investments in healthcare infrastructure, and strong focus on innovation in medical technology. According to Misra, the approval enables QT Imaging to move forward with commercial deployment alongside its distribution partner Gulf Medical Co., expanding access to its novel imaging platform across the Kingdom.
He also noted that regulatory clearance in Saudi Arabia reinforces QT Imaging’s ability to successfully navigate international regulatory frameworks, demonstrating the company’s readiness for broader global expansion.
Strengthening Presence Across the Gulf Region
With regulatory approvals now secured in both Saudi Arabia and the United Arab Emirates, QT Imaging has established a commercial foundation in two of the largest and most influential healthcare markets in the Gulf Cooperation Council (GCC) region.
This regional presence is expected to serve as a strategic base for further expansion across the Middle East and potentially other international markets. The Gulf region has been investing heavily in advanced healthcare technologies, particularly in diagnostic imaging, digital health, and preventive medicine, creating a favorable environment for the adoption of innovative medical devices.
The company’s expanding footprint in the region reflects a broader strategy to introduce its Breast Acoustic CT™ platform to markets that prioritize early cancer detection, patient-centered care, and technological innovation in healthcare delivery.
Breast Cancer and the Importance of Early Detection
Breast cancer remains a major public health concern globally and is the leading cancer diagnosis among women in Saudi Arabia. Early detection is widely recognized as one of the most important factors in improving survival rates and treatment outcomes.
However, screening participation rates can be influenced by accessibility, patient comfort, and awareness of available diagnostic options. Technologies that improve patient experience and reduce barriers to screening are therefore increasingly important in expanding public health impact.
QT Imaging’s radiation-free and compression-free imaging system is designed to contribute to these efforts by offering an alternative approach to breast imaging that may encourage more women to participate in routine screening programs.
Advancing Commercialization in International Markets
The SFDA clearance is part of QT Imaging’s broader strategy to expand commercialization of its Breast Acoustic CT™ technology beyond the United States. International regulatory approvals are a key component of this strategy, enabling the company to access new healthcare markets and build partnerships with regional distributors and healthcare providers.
By securing approvals in multiple jurisdictions, QT Imaging is working to establish a global presence in the breast imaging sector, positioning its technology as an alternative to traditional mammography systems.
The company’s focus on regulatory progress, strategic partnerships, and regional market entry reflects its commitment to scaling adoption of its imaging platform in healthcare systems around the world.
With regulatory clearance now in place in Saudi Arabia and an established distribution partnership with Gulf Medical Co., QT Imaging is preparing for the next phase of commercial deployment in the region. This includes engagement with healthcare institutions, installation of imaging systems, and integration into clinical workflows across the Kingdom.
As Saudi Arabia continues to invest in healthcare modernization under Vision 2030, demand for advanced diagnostic technologies is expected to grow, particularly in areas such as women’s health and cancer screening.
QT Imaging’s entry into the Saudi market represents an important step in its global expansion strategy and highlights the increasing international interest in non-invasive, patient-friendly imaging technologies. The company is now positioned to further expand its presence across the Middle East while continuing to pursue additional regulatory approvals in other global markets.
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.
