QT Imaging Holdings, Inc. $QTI

What the company doesAI summary of filing

QT Imaging Holdings, Inc. is a medical device company founded in 2012 that develops and commercializes body imaging systems using low-energy transmitted sound waves. The company has developed the QT Breast Scanner (Breast Acoustic CT™), a Class II device that received FDA 510(k) clearance in 2017 and additional clearances in 2022 and 2026, designed to produce high-resolution three-dimensional images of breast tissue without ionizing radiation or breast compression. The company generates revenue through the sale and lease of QT Breast Scanners and related services, with current FDA clearance for adjunctive breast imaging in cases such as dense breasts, high-risk patients, and therapy monitoring; it is developing a cloud-based software-as-a-service platform with artificial intelligence and machine learning algorithms to deliver quantitative imaging biomarkers and precision diagnostics. The company is revenue-generating and is pursuing geographic expansion through strategic distribution partnerships, including an exclusive distribution agreement with NXC Imaging, Inc. (a subsidiary of Canon Medical Systems Corporation) for the U.S. market and partnerships in the Gulf Cooperation Council region. [10-K 2026-03-25]

Segments: QT Breast Scanner (Breast Acoustic CT™), Cloud SaaS precision diagnostics platform, Imaging informatics and post-processing services