As breast imaging continues to evolve toward more quantitative and patient-centred approaches, QT Imaging is developing a three-dimensional ultrasound platform designed to provide detailed breast imaging without ionising radiation, compression or contrast injection. The company’s Breast Acoustic CT platform combines reflection and transmission ultrasound to generate co-registered 3D images and quantitative measurements of breast tissue, including fibroglandular tissue volume and breast composition.

In this interview, Dr. Raluca Dinu, CEO of QT Imaging, discusses the clinical potential of the technology, particularly for women with dense breasts, the priorities for expanding adoption across healthcare settings, the role of quantitative imaging and the company’s plans for the next 12–18 months.

QT Imaging's 3D ultrasound platform offers a radiation-free and compression-free approach to breast imaging. What clinical advantages have you observed compared with conventional mammography and ultrasound?

The clinical value of our Breast Acoustic CT platform begins with the fact that we are acquiring true three-dimensional, quantitative information about the breast without ionizing radiation, compression or contrast injection. That combination is particularly important in breast imaging, where we want to obtain clinically useful information while also making the examination as comfortable and reproducible as possible for the patient.

Unlike conventional handheld ultrasound, which can be highly dependent on the operator and the imaging plane selected during the examination, our system performs an automated, standardized scan of the breast. It acquires both reflection and transmission ultrasound data around the breast and reconstructs co-registered 3D volumes. Transmission imaging provides quantitative measurements such as speed of sound, while reflection imaging provides high-resolution visualization of tissue interfaces. The system can also quantitatively measure fibroglandular tissue volume and the ratio of fibroglandular tissue to total breast volume. These capabilities are part of the technology's FDA-cleared functionality.

Breast density is particularly relevant because it can reduce the sensitivity of mammography. Dense breasts contain a higher proportion of fibroglandular tissue relative to fatty tissue. On mammography, fibroglandular tissue appears radiopaque, or white, and many breast cancers also appear as areas of increased radiographic density. This similarity in x-ray appearance can create a “masking effect,” in which a lesion is partially or completely obscured by surrounding dense tissue, making some cancers more difficult to detect. In contrast, ultrasound relies on the propagation and interaction of acoustic waves with tissue rather than x-ray attenuation. Advanced ultrasound approaches that acquire three-dimensional and quantitative information therefore have the potential to provide complementary tissue information in dense breasts, where mammographic visualization may be limited.

Our goal is not simply to produce another breast image, but to provide complementary, quantitative information that can help clinicians characterize breast tissue and evaluate findings while avoiding additional radiation or compression. Importantly, Breast Acoustic CT imaging modality is a supplemental breast-imaging technology; it is not positioned as a replacement for mammography.

QT Imaging has progressively expanded the FDA-cleared capabilities of its technology, since our first FDA clearance in 2017, from three-dimensional reflection and transmission ultrasound imaging of the breast, to quantitative measurement of fibroglandular tissue and breast composition, and most recently to an enhanced scanner configuration that improves imaging coverage of posterior breast tissue near the chest wall. Together, these clearances reflect the evolution of our technology from a 3D ultrasound imaging system toward a more comprehensive quantitative breast-imaging platform.

Following FDA clearance, what are QT Imaging's key priorities for expanding adoption among hospitals, imaging centers, and breast health specialists?

Our priority is to move from regulatory validation to broad, sustainable clinical adoption. That means building the clinical evidence, reimbursement infrastructure, workflow integration, physician education, and commercial support necessary for Breast Acoustic CT imaging modality to become part of routine breast-imaging practice.

First, we are continuing to strengthen the clinical evidence, particularly in areas where current breast-imaging pathways have limitations, including women with dense breasts and those who may benefit from supplemental imaging. We are working with leading clinical institutions to evaluate how the quantitative and three-dimensional information generated by Breast Acoustic CT imaging modality correlates with established modalities and can contribute to clinical decision-making.

Second, reimbursement is essential for adoption at scale. The AMA's approval of Category III CPT code X579T for 3D quantitative transmission volumetric ultrasound tomography of the breast, effective January 1, 2027, is an important milestone. It provides a standardized mechanism for reporting and tracking utilization and represents an important step toward broader reimbursement.

Third, we are focused on integrating the technology into existing breast-imaging workflows. Breast imaging is inherently multimodal, so radiologists need to correlate QT images with mammography, MRI, and other studies. Our multimodality viewing and cloud infrastructure are designed to support this integration, including longitudinal comparison and connectivity with established PACS environments.

Physician education is equally important. Breast Acoustic CT imaging modality provides information that differs from conventional ultrasound, including 3D reflection and transmission imaging and quantitative measurements of breast tissue. Building familiarity among breast radiologists and specialists is therefore an important part of responsible adoption.

Finally, we are expanding the commercial and service infrastructure required to scale, including strategic distribution relationships in the United States and regulatory and distribution initiatives internationally.

How do you see quantitative imaging and advanced ultrasound technologies improving the early detection and diagnosis of breast cancer, particularly for women with dense breast tissue?

QTI Breast Acoustic CT imaging modality approaches the breast differently. Rather than relying on X-ray attenuation, it uses both transmission and reflection ultrasound to acquire a standardized, fully three-dimensional dataset. Transmission imaging measures intrinsic acoustic properties of tissue, including speed of sound and attenuation, while reflection imaging provides high-resolution anatomical and structural information. These datasets are spatially co-registered, allowing the radiologist to evaluate tissue anatomy and quantitative tissue properties together.

Importantly, speed of sound varies with tissue composition and provides the basis for quantitative assessment of fibroglandular tissue. QT Imaging’s FDA-cleared software calculates fibroglandular tissue volume, or FGV, as well as the ratio of FGV to total breast volume. This provides an objective, volumetric measurement of breast composition rather than relying solely on a qualitative visual assessment.

We believe the broader opportunity is to move breast imaging from primarily qualitative image interpretation toward quantitative, reproducible tissue characterization. Because these measurements are generated from standardized 3D datasets, they also create the potential for longitudinal comparison, measuring how breast tissue or a finding changes over time, and for developing additional imaging biomarkers and AI-based analytical tools.

What milestones or product developments can we expect from QT Imaging over the next 12–18 months, including any clinical, regulatory, or commercial initiatives?

Over the next 12–18 months, our priorities are very clear. We are focused on accelerating commercial adoption and expanding our installed base through both distribution partnerships and our direct commercial capabilities.

At the same time, we will continue strengthening the clinical and scientific foundation of Breast Acoustic CT platform by expanding clinical evidence, advancing quantitative imaging biomarkers and deepening collaborations with leading academic and clinical institutions.

We are also focused on expanding global market access through U.S. reimbursement, additional international regulatory authorizations and new commercial opportunities. On the technology side, we will continue advancing image reconstruction, quantitative imaging, the QT Imaging Precision Pathway™ cloud platform and future AI-enabled clinical applications, supported by rigorous clinical validation and appropriate regulatory pathways.

• Looking ahead, what is your long-term vision for QT Imaging, and how do you see the company shaping the future of precision breast health diagnostics?

Our mission is to transform breast health for every woman by addressing fundamental limitations in today’s breast imaging pathway. More than 12,000 women have now been imaged using Breast Acoustic CT imaging modality, providing growing real-world clinical experience and reinforcing our commitment to improving both the patient experience and the information available to physicians.

Our long-term vision extends beyond introducing another breast imaging system. We are building a quantitative breast imaging platform that integrates advanced hardware, software, cloud infrastructure and, over time, AI-enabled clinical applications. Our goal is to provide objective, reproducible and quantitative information that complements today’s imaging standards and supports a more personalized approach to breast health.

We believe the future of precision breast health will increasingly involve quantitative and longitudinal assessment, understanding not only what breast tissue looks like today, but how measurable tissue characteristics change over time. Ultimately, we want QT Imaging to help advance a more patient-centered, data-driven and personalized model of breast health management.