QT Imaging Secures UAE Regulatory Clearance

QT Imaging Holdings Inc.’s Breast Acoustic CT scanner has received official classification and clearance from the United Arab Emirates (UAE) Emirates Drug Establishment (EDE) for use as a medical device.

The clearance allows QT Imaging to import and distribute its scanner through EDE-licensed medical warehouses, thereby ensuring compliance with UAE healthcare infrastructure standards and enabling the company to market the scanner to licensed healthcare facilities across the country. It also represents a significant step in QT Imaging’s global strategy and reinforces its commitment to expanding access to advanced compression-free, 3D technology offering a more comfortable and radiation-free alternative for breast imaging, according to bigwigs.

QT Imaging signed an exclusive distribution agreement in January with Al Naghi Medical Co., a UAE medical device provider for the QTI scanner and the QTI Cloud Platform, establishing a $24 million revenue pipeline through 2028. Breast cancer accounts for 25% of all cancer cases in the UAE and 43% of cancers among women, according to national data cited by Elobaid et al.¹

“The UAE represents a highly attractive and fast-growing healthcare market, and this regulatory clearance is a pivotal milestone in our expanding global commercial presence,” QT Imaging Chief Commercial Officer Satrajit Misra stated. “It opens the door for commercial deployment in the region by our distributor, Al Naghi Medical, positions us to build strong partnerships with leading healthcare providers, and also complements our existing presence in Saudi Arabia through Gulf Medical.”

With a strong emphasis on innovation and regulatory alignment, QT Imaging is advancing its global commercialization efforts. In addition to QT Imaging’s exclusive distribution agreement with Gulf Medical Co. for Saudi Arabia, the company now has a commercial presence in the two largest healthcare markets in the Middle East.

QT Imaging Holdings researches, develops, and commercializes imaging systems using low-frequency sound waves. The company strives to improve global health outcomes; its strategy is based on the fact that medical imaging is critical to detecting, diagnosing, and treating disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. Breast Acoustic CT is a trademark of a QT Imaging Holdings affiliate.

Reference
¹ Y. Elobaid, T. C. Aw, J. N. W. Lim, S. Hamid, and M. Grivna, “Breast Cancer Presentation Delays Among Arab and National Women in the UAE: A Qualitative Study,” SSM Popul Health 2 (2016): 155–163.å