QT Imaging Receives FDA Clearance for Its Breast Acoustic CT Scanner Enhanced Configuration to Improve Posterior Breast Imaging Coverage

Key Terms

510(k) clearance regulatory

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

tomographic medical

Relating to tomography, tomographic describes imaging methods that create detailed cross‑sectional pictures of the inside of an object or body, as if slicing a loaf of bread and viewing each slice. Investors care because tomographic technologies (like CT or MRI) are central to diagnostics and treatment planning, affecting demand for medical devices, recurring service revenue, regulatory approval hurdles, and reimbursement policies that can influence a healthcare company’s growth and profitability.

fibroglandular tissue volume medical

The amount of fibroglandular tissue volume is a measurement of the dense, glandular and connective tissue in the breast compared with fatty tissue. Think of it like comparing firm sponge material to soft padding — higher fibroglandular volume means denser breast tissue, which can make imaging harder to read and affect screening accuracy. Investors care because tissue density influences demand for advanced imaging, diagnostic services, and related medical devices or treatments.

transmission-mode technical

How a disease or biological agent spreads from one person or source to another — for example through the air, close contact, contaminated surfaces, or insects — is called its transmission mode. Investors pay attention because different spread routes change how quickly outbreaks can grow, which products or services become needed, and what regulations or public responses may follow; think of it like knowing whether a fire spreads by sparks, fuel, or wind when deciding how to protect assets.

NOVATO, Calif.--(BUSINESS WIRE)-- 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 receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for an updated configuration of its Breast Acoustic CT™ scanner, the Company’s 3D ultrasound tomographic breast imaging system. The newly cleared enhanced configuration improves visualization and expands coverage of posterior breast tissue.

“The updated configuration cleared by the FDA incorporates a tilted transmitter geometry that improves tomographic imaging coverage of breast tissue located near the chest wall, which is an area that can be extremely challenging to capture,” said Bilal Malik, PhD, Chief Science Officer of QT Imaging. “This design delivers more complete coverage and improved overall diagnostic utility by optimizing the scanner’s ability to include posterior breast tissue that is often difficult to image with standard approaches. We remain dedicated to developing and refining innovative technologies that provide greater precision and confidence to deliver the best outcomes for women regardless of breast density.”

The QTI Breast Acoustic CT scanner generates both reflection-mode and transmission-mode ultrasound data to reconstruct 3D tomographic images. Its proprietary software quantifies fibroglandular tissue volume (FGV) and the ratio of fibroglandular tissue to total breast volume (TBV), providing valuable insight for breast health assessment and monitoring.

About QT Imaging

QT Imaging Holdings, Inc. (Nasdaq: QTI) is a medical device company engaged in the research, development, and commercialization of innovative imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging Holdings, Inc., please visit the Company’s website at www.qtimaging.com.

Breast Acoustic CT™ is a trademark of an affiliate of QT Imaging Holdings, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the QT Imaging Breast Acoustic CT™ Scanner, including its commercialization, manufacturing (including large scale) and further development, advanced image reconstruction software performance of software enhancements, plans for QT Imaging, new product development and introduction, product sales growth and projected revenues, QT Imaging’s industry, future events, and other statements that are not historical facts. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of QT Imaging's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by you or any other investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control. These forward-looking statements are subject to a number of risks and uncertainties, including those relating to: the ability of the Company to sell and deploy the QT Imaging Breast Acoustic CT™ Scanner; the ability to extend product offerings into new areas or products; the ability to commercialize technology; unexpected occurrences that deter the full documentation and “bring to market” plan for products; trends and fluctuations in the industry; changes in demand and purchasing volume of customers; unpredictability of suppliers; the ability to attract and retain qualified personnel and the ability to move product sales to production levels; changes in domestic and foreign business, market, financial, political, and legal conditions; the uncertainty of projected financial information; delays caused by factors outside of our control; changes in our ability to successfully receive purchase orders and generate revenue under our existing contracts with partners and distributors; our ability to realize the benefits of the strategic partnerships; the identified material weakness in our internal controls over financial reporting (including the timeline to remediate the material weakness); the rollout of the business and the timing of expected business milestones; the effects of competition on our future business; our ability to obtain and access financing in the future; our ability to pay our debt obligations as they come due; and those factors discussed in the Company’s reports and other documents filed with the SEC, including under the heading “Risk Factors.” If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that QT Imaging presently does not know or that QT Imaging currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect QT Imaging's expectations, plans or forecasts of future events and views as of the date of this release. QT Imaging anticipates that subsequent events and developments will cause QT Imaging's assessments to change. However, while QT Imaging may elect to update these forward-looking statements at some point in the future, QT Imaging specifically disclaims any obligation to do so. Accordingly, undue reliance should not be placed upon the forward-looking statements.

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Source: QT Imaging Holdings, Inc.