QT Imaging Secures Medicare Outpatient Reimbursement for QTscan®, Effective January 2027

CMS reverses proposed nonpayment decision, establishing separate Medicare payment for eligible diagnostic QTscan examinations

PETALUMA, 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 that the Centers for Medicare & Medicaid Services (CMS) has established a separately payable Medicare hospital outpatient classification for diagnostic QTscan® examinations, effective January 1, 2027.

CMS recognized that QTscan diagnostic services can qualify under an existing Medicare benefit category and established a separate hospital outpatient payment classification. The decision reverses CMS’s earlier proposal to classify QTscan examinations as nonpayable and represents a significant milestone in QT Imaging’s reimbursement and commercialization strategy.

“This is an important milestone for QT Imaging and the hospitals and imaging providers seeking to bring our technology to more women,” said Dr. Raluca Dinu, Chief Executive Officer of QT Imaging. “CMS’s decision establishes separate Medicare hospital outpatient payment for medically necessary, physician-ordered diagnostic QTscan examinations and removes the reimbursement uncertainty. We are now focused on translating this progress into broader clinical adoption, supporting providers with coding and billing guidance, strengthening our engagement with Medicare and commercial payers, and expanding the clinical evidence demonstrating QTscan’s diagnostic value.”

Under the final 2027 Medicare Hospital Outpatient Prospective Payment System (OPPS) rule, CMS assigned QTscan’s dedicated CPT® code 1079T to Ambulatory Payment Classification (APC) 5522, with status indicator “S,” establishing separate Medicare hospital outpatient payment beginning January 1, 2027. Importantly, CMS recognized that physician-ordered QTscan examinations addressing specific diagnostic findings qualify under Medicare’s existing diagnostic ultrasound coverage framework.

With CPT code 1079T effective October 1, 2026, and separate Medicare hospital outpatient payment beginning January 1, 2027, QT Imaging has achieved two critical reimbursement milestones. Together, these developments provide hospitals with a dedicated billing code and an established Medicare payment classification for diagnostic QTscan examinations, supporting broader hospital adoption and commercial expansion across the United States.

Medicare coverage and payment remain subject to medical necessity and documentation requirements. QTscan examinations must be physician-ordered to address a specific diagnostic question. Routine screening of asymptomatic patients is not covered under current Medicare rules.

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 that use 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 and follow us on LinkedIn.

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 implementation and potential benefits of the CMS payment classification, Medicare coverage and payment for QTscan diagnostic services, the Company’s reimbursement strategy and payer engagement, clinical evidence generation, provider adoption, commercialization, 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: changes in reimbursement policies and payer coverage and payment determinations; the ability of providers to satisfy applicable medical necessity and claims documentation requirements; 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.

Investors
CORE IR
Tirth Patel
ir@qtimaging.com
386-295-2215

Media
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Matthew Cossel
pr@qtimaging.com
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Source: QT Imaging Holdings, Inc.

Released November 9, 2026