QTI News & Events

QT Imaging announced receipt of 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 company said, "The Company expects 2026 revenue to be approximately $39 million, including shipments of scanners and initial revenue from its SaaS Cloud Platform. These targets are in accordance with the minimum order quantities per its Amended Distribution Agreement with its strategic business and distribution partner in the United States, NXC Imaging, Inc., a wholly owned subsidiary of Canon Medical Systems USA, as well as its new distribution partners in the Gulf region, Gulf Medical and Al Naghi Medical."

Reports preliminary Q4 revenue $8.28M vs. $847,000 last year. "Q4 marked a pivotal moment for the Company with record quarterly revenue driven by a record number of scanners shipped, and strong execution across our commercial and product initiatives," said Raluca Dinu, CEO. "Exceeding our 2025 revenue outlook and successfully relisting on Nasdaq in under a year underscore the strength of our team, the resilience of our strategy and growing patient awareness and demand for our breast imaging alternative. As we continue our transition from a traditional scanner company to a SaaS and biomarker-driven medical imaging platform, we believe we are building a scalable, data centric business positioned for long-term growth."