By Melane Sampson
QT Imaging Holdings (OTCQB: QTIH) is reshaping the breast imaging landscape through a convergence of quantitative ultrasound, artificial intelligence (AI), and biomarker science—delivering a safer, more accessible alternative to traditional imaging modalities.
“We are FDA cleared as a safe breast imaging modality for patients 18 years of age and above. We are not replacing mammography—we’re part of the ecosystem. Our technology fills the gap for women with dense breasts, high-risk younger women, those who can’t tolerate MRI, or who want an imaging experience without pain, compression, or radiation,” Raluca Dinu, PhD, CEO of QT Imaging (QTI), says in an interview with BioTuesdays.
QTI has developed the Breast Acoustic CT Scanner with QTViewer, the first FDA-cleared 3D transmission and reflection ultrasound platform for breast imaging. Designed to address the diagnostic gaps in dense breast tissue and improve patient comfort, QTI’s system is positioning itself as a critical complement to mammography and MRI.
A breakthrough approach to imaging, Quantitative Transmission (QT) ultrasound is a 3D volumetric modality that uses a CT-like configuration with ultrasound waves to map the speed of sound across breast tissue. This enables clinicians to visualize the entire breast without tissue overlap—offering MRI-level resolution without contrast agents, radiation, or discomfort.
Patients lie comfortably in a prone position with the breast submerged in water as ultrasound arrays rotate 360 degrees around it, completing each scan in about 10 to 12 minutes per breast. “It’s a completely pain-free experience,” Dr. Dinu notes. “We’ve actually had patients fall asleep during the process.”
Unlike conventional hand-held ultrasound, QTI’s system provides standardized, operator-independent scanning—a key factor in reducing variability and improving reproducibility across clinics.
The company’s Breast Acoustic CT Scanner with QTViewer is the only 3D ultrasound platform to receive FDA clearance for both transmission and reflection imaging of the breast. In addition, the system is cleared for quantitative assessment of fibroglandular tissue volume and breast density—a first for ultrasound-based technology.
The FDA granted the device 510(k) clearance as a supplementary screening tool, finding it substantially equivalent in safety and efficacy to existing breast imaging modalities such as MRI. In 2018, the scanner also received the FDA’s Breakthrough Device Designation, fast-tracking its path toward unique CPT codes and future clearances.
“These regulatory milestones recognize that our system meets an unmet medical need—especially for women with dense breasts, who are often underserved by mammography,” Dr. Dinu contends.
Addressing dense breast challenges, Dr. Dinu says an estimated 40–50% of women in the U.S. have dense breast tissue, which can obscure tumors on mammograms. “Studies show mammography can miss up to half of cancers in dense breasts. The FDA recently ruled that providers must inform patients of their breast density and discuss supplemental screening options.” QTI’s solution fits directly into that mandate.
“The quality of our images is very similar to MRI,” Dr. Dinu explains. “We plan to provide quantitative data—biomarkers—that help radiologists move from subjective interpretation toward measurable, data-driven assessment.”
She points out that over the past year, QTI has undergone a major transformation—from a hardware-focused startup to a biomarker-driven AI imaging company. Its platform captures volumetric acoustic data that can be analyzed to generate quantitative biomarkers—measurable indicators of tissue composition, stiffness, and structure.
These biomarkers can support cancer probability mapping, therapy monitoring, and personalized medicine. Through machine learning, the company’s cloud-connected software continuously refines its algorithms to improve diagnostic accuracy.
“Our job is to define the right biomarker set and use AI to build a probability of cancer map,” Dr. Dinu says. “That’s the holy grail for breast imaging—moving from subjective reading to quantifiable precision.”
Following a corporate turnaround in 2024, QTI has reestablished momentum both operationally and financially. The company recently submitted its application to relist on the Nasdaq Capital Market, supported by a 3:1 reverse stock split to meet listing requirements.
“Our application to relist on Nasdaq less than a year after leaving the exchange, coupled with a conservative reverse split ratio, is a testament to the strong growth trajectory of our business,” Dr. Dinu asserts. “It marks a significant step toward long-term shareholder value and expanding our investor base.”
Since going public in early 2024, QTI has scaled from a small team with no shipments to delivering 12 scanners in 2024, with projections of 40 units in 2025 and 60 in 2026 across the U.S., and an additional 20 scanners to be sold in Saudi Arabia in 2026. The company has also secured $18 million in NIH funding and more than $100 million in private investment, underscoring institutional confidence in its mission and technology.
Recently, QTI announced that it had submitted its application to relist on the Nasdaq Capital Market. In the press release, Dr. Dinu stated that the application to relist on Nasdaq less than a year after leaving the exchange, coupled with a conservative reverse stock split ratio, was a testament to the exciting momentum and strong growth trajectory in QTI’s business. And moving back to a national exchange represents a significant step toward creating long-term stockholder value and attracting a broader, more diverse stockholder base.
Moving forward, Dr. Dinu highlights that QTI’s mission extends beyond technology—it’s about patient access. MRI machines are expensive and limited in availability, while mammography relies on ionizing radiation. QTI’s system offers safe, accessible, scalable MRI-quality imaging at a fraction of the cost, making it viable for broader population screening and frequent monitoring. Its non-ionizing, non-compressive, and operator-independent workflow also makes it suitable for women under 40 or those requiring repeat imaging for therapy monitoring.
“We can measure tumor volume over time to assess whether treatment is working—without exposing patients to radiation,” Dr. Dinu says. “This is personalized medicine in action.”
Looking ahead, the company’s roadmap includes cloud-based AI integration via its upcoming SaaS platform, which will enable automated reconstruction, feature extraction, and probability map generation from uploaded clinical data.
As Dr. Dinu explains, “We’re creating an intelligent, adaptive ecosystem for breast imaging—one that continuously learns and improves with every patient scanned.”
With FDA clearances, AI-driven analytics, and growing clinical adoption, QTI is poised to redefine the standard of care for breast health diagnostics—bringing safety, accuracy, and comfort together in one evolving platform.
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