QT Imaging trims 2026 sales outlook to $34m as Medicare payment route opens
The breast-imaging company has secured a US reimbursement pathway for hospital diagnostic scans from 2027, but shipment slippage in the Gulf has cost it about $5m of expected 2026 sales.
QT Imaging Holdings now expects roughly $34m in revenue for 2026, down from the $39m it had guided to previously. The company attributes the roughly 13% cut to late deliveries of its QTscan systems to customers in Saudi Arabia and the United Arab Emirates, which it links to regional hostilities. It reported third-quarter sales of $7.3m on 10 November, taking the nine-month total to $21.3m.
Set against the new outlook, the nine-month figure implies about $12.7m in the final quarter, well above the third-quarter run rate. That is our arithmetic from the reported numbers, not a company statement, and it leaves the delayed Gulf deliveries carrying a good deal of the year-end weight.
The more durable news is in the US. On 4 November the Centers for Medicare & Medicaid Services dropped its earlier plan to withhold payment for the technology. It placed diagnostic QTscan breast exams under Category III CPT code 1079T, mapped to ambulatory payment classification 5522. Hospital outpatient reimbursement starts on 1 January 2027. Routine screening use is outside the coverage. As general context, Category III codes are temporary trackers for emerging technologies and do not on their own confer payment; here, the APC assignment is what creates the payment route. The payment rate was not among the details provided.
On compliance, QT Imaging said its first routine FDA inspection ended with no Form 483 observations. It also reported regulatory authorisations in Israel and Bahrain.
Why it matters
- Medicare payment applies only to diagnostic QTscan exams in hospital outpatient settings from 1 January 2027; the screening market is not opened by this decision.
- The shift from a proposed no-pay position to an assigned payment class shows how far a reimbursement outcome can move between proposal and final decision.
- A $5m guidance cut from delayed Gulf shipments shows how geopolitical disruption can move delivery timing and revenue for export-reliant device makers.
- A first routine FDA inspection with zero Form 483 observations is a positive regulatory marker for a young device company.
Company's press release (SEC filing): Qt Imaging Holdings, Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.