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QT Imaging Receives Saudi Arabia FDA Regulatory Clearance

  • QT Imaging Holdings, Inc. received official SFDA classification & clearance in Saudi Arabia for its Breast Acoustic CT™ scanner as a medical device.
  • The approval enables marketing, sales, & commercial deployment of the radiation-free 3D breast imaging technology throughout the Kingdom.
  • Gulf Medical Co., the exclusive distribution partner selected in August 2025, is now positioned to begin commercial activities with healthcare institutions.
  • Saudi Arabia's Vision 2030 & Health Sector Transformation Program drive demand for advanced imaging due to breast cancer being the most diagnosed cancer among women.
  • QT Imaging has secured regulatory clearances in both Saudi Arabia & the United Arab Emirates, establishing a commercial foundation in the two largest Gulf healthcare markets.
  • Satrajit Misra, Chief Commercial Officer, stated the approval is a major achievement for global commercialization & expands access to compression-free technology.
  • The company operates as a medical device firm focused on low-frequency sound wave imaging systems to improve safety, affordability, & patient experience.
  • The press release includes forward-looking statements regarding future revenue, product development, & commercialization plans accompanied by standard risk disclosures.