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QT Imaging wins Medicare outpatient payment for QTscan but cuts 2026 revenue guidance to $34M

🇺🇸 Qt Imaging Holdings, Inc. (QTI) · Tue 10 Nov 2026

CMS reversed its proposed nonpayment stance on QTscan diagnostic breast exams, while Middle East conflict delayed shipments and pushed the company to lower its full-year outlook.

QT Imaging reported third-quarter revenue of $7.3 million on 10 November 2026, with nine-month revenue reaching $21.3 million. The company lowered its full-year guidance to about $34 million, down from $39 million, citing delays to scanner shipments to Saudi Arabia and the United Arab Emirates linked to conflict in the Middle East.

The company said the US Centers for Medicare & Medicaid Services (CMS) on 4 November 2026 reversed its earlier proposal not to pay for the technology. CMS assigned CPT Category III code 1079T to Ambulatory Payment Classification (APC) 5522 for diagnostic QTscan breast imaging exams. Medicare hospital outpatient payment is due to begin on 1 January 2027. Routine screening use is not covered.

For context, Category III CPT codes are temporary codes used to track emerging technologies and services, and they do not by themselves guarantee payment. In this case, the APC assignment sets the Medicare hospital outpatient payment pathway for diagnostic exams.

On the regulatory side, QT Imaging reported its first routine FDA inspection, which closed with zero Form 483 observations. It also said it has received regulatory authorizations in Israel and Bahrain.

What it means for your team

  • Market-access teams should note that the Medicare coverage is limited to diagnostic QTscan breast exams in the hospital outpatient setting from 1 January 2027, and excludes routine screening.
  • The CMS reversal from a proposed nonpayment position shows that reimbursement outcomes for novel imaging can change between proposal and final decisions.
  • Quality and regulatory teams may take the zero-observation Form 483 outcome as a positive marker of inspection readiness for a company in its first routine FDA inspection.
  • Export-dependent device makers should factor geopolitical shipment risk in the Middle East into revenue and delivery planning, as this guidance cut illustrates.

Company's press release (SEC filing): Qt Imaging Holdings, Inc. ↗

Article written by VigiEye from the official source (Qt Imaging Holdings, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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