QT Imaging Receives Israeli Ministry of Health Regulatory Registration
Regulatory approval enables commercialization of QT Imaging's technology in Israel and supports expansion of clinical research collaborations
QT Imaging Holdings, Inc.(Nasdaq: QTI) (“QT Imaging” or the “Company”), a medical device company dedicated to transforming breast health management through innovative, radiation-free imaging technology, today announced that the Israeli Ministry of Health has granted registration for the Company's scanner, authorizing commercialization of the system in Israel through February 2, 2028. The approval is based on the Company's existing U.S. FDA clearance and applicable Israeli regulatory requirements.
QT Imaging’s Breast Acoustic CT™ Scanner produces true 3D, radiation-free and compression-free images of the breast using low-energy sound waves. The system provides quantitative imaging biomarkers derived from the intrinsic acoustic properties of breast tissue. The system is FDA-cleared as an adjunctive breast imaging device for women 18 years of age and older.
"This regulatory milestone is another important step in QT Imaging's international commercialization strategy," said Dr. Raluca Dinu, QT Imaging’s Chief Executive Officer. "Israel is internationally recognized for its leadership in breast cancer research, clinical innovation, and precision medicine. We are excited to bring our technology to Israeli clinicians while expanding collaborations with leading academic and clinical institutions."
