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QT Imaging Holdings, Inc.
Medical device company dedicated to transforming breast health management through radiation-free imaging technology combining Quantitative Transmission (QT) ultrasound, AI, and biomarkers.
- Founded
- Not disclosed
- Headquarters
- Not disclosed
- Company size
- Not disclosed
- Products tracked
- 2
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Trust profile
Security and compliance
FIPS 140-3
FDA 510(k) clearance — quantitative assessment of breast fibroglandular volume and density
FDA Breakthrough Device designation (2018)
FDA routine inspection with zero Form 483 observations
California Shine the Light law (Cal. Civ. Code § 1798.83)
Data security safeguards (implemented to protect personal information from loss, misuse, unauthorized access, disclosure, alteration, and destruction)
Latest updates from QT Imaging Holdings, Inc.
Company news
QT Imaging Completes First FDA Routine Inspection with No Observations
QT Imaging Holdings, Inc. successfully completed its first routine U.S. Food and Drug Administration (FDA) inspection of its Quality Management System (QMS). The company received zero Form 483 observations, indicating that the inspector found no conditions constituting violations of the Food, Drug and Cosmetic Act and related regulations during the review of the company's operational processes.
MentionedU.S. Food and Drug Administration
Research
QT Imaging Publishes Reproducibility Results for Breast Imaging Biomarkers
QT Imaging reported results from a multi-site study characterizing the repeatability and reproducibility of quantitative biomarkers produced by its Breast Acoustic CT Scanner platform. The study found that Speed of Sound measurements achieved a within-subject coefficient of variation of less than 1%, while volumetric measurements showed variability between 5% and 12%. The research highlights the platform's consistency compared to published benchmarks for breast MRI, supporting its application for longitudinal patient monitoring and quantitative clinical assessment.
MentionedRSNA Quantitative Imaging Biomarkers Alliance