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QT Imaging Receives Israeli Ministry of Health Regulatory Registration

QTI
  • QT Imaging Holdings, Inc. received regulatory approval from the Israeli Ministry of Health to commercialize its Breast Acoustic CT™ Scanner in Israel through February 2, 2028.
  • The approval is based on the company's existing U.S. FDA clearance & compliance with applicable Israeli regulatory requirements.
  • The Breast Acoustic CT™ Scanner utilizes low-energy sound waves to produce true 3D, radiation-free, & compression-free images of breast tissue.
  • The system is FDA-cleared as an adjunctive breast imaging device for women aged 18 years & older.
  • The registration supports expanded clinical research collaborations, specifically a planned study at Rambam Health Care Campus to evaluate the technology in women with hereditary breast cancer risk.
  • Israel is identified as a key setting for hereditary breast cancer research due to its national BRCA1/2 screening program & expertise in hereditary cancer management.
  • Dr. Raluca Dinu, Chief Executive Officer, stated the milestone advances the company's international commercialization strategy & enables partnerships with leading Israeli academic institutions.
  • The company notes that its quantitative imaging offers objective tissue characterization without ionizing radiation or breast compression.
  • The press release includes standard forward-looking statements regarding future events, risks, & uncertainties that could cause actual results to differ from expectations.