QT Imaging Receives FDA 510(k) Clearance for Updated Breast CT Scanner
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
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Should l Buy QTI?
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.
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Analyst Views on QTI
Wall Street analysts forecast QTI stock price to rise
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About QTI
QT Imaging Holdings, Inc. is a medical device company engaged in the research, development, and commercialization of body imaging systems using low-frequency sound waves. The Company's products include QTI Breast Acoustic CT Scanner and QTviewer Software. QTI’s Breast Acoustic CT scanner with QTViewer viewer software is the only three-dimensional (3D) imaging device to receive United States Food and Drug Administration (FDA) clearance for use as a transmission and reflection ultrasonic imaging system of a patients breast. QTviewer is its proprietary image viewing and analysis platform, purpose-built to interpret the rich, quantitative datasets generated by the QTI Breast Acoustic CT™ scanner. The QTviewer allows users to rotate, zoom, and cross-navigate entire breast volumes. Whether isolating lesions or exploring architectural distortion, radiologists can interact with the data dynamically to gain an understanding of tissue structure and lesion morphology.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
QT Imaging Receives FDA Clearance for Enhanced Breast Imaging Technology
- FDA Approval for New Configuration: QT Imaging's Breast Acoustic CT™ scanner has received FDA 510(k) clearance for an updated configuration that enhances imaging coverage of breast tissue near the chest wall, significantly improving diagnostic capabilities and potentially strengthening the company's market position in breast health management.
- Technological Innovation: The new configuration optimizes the scanner's ability to image posterior breast tissue, an area often challenging to capture with standard methods, thereby enhancing overall diagnostic utility and addressing the market demand for high-precision breast imaging solutions.
- Enhanced Data Processing: The scanner generates both reflection-mode and transmission-mode ultrasound data to reconstruct 3D images and quantify fibroglandular tissue volume (FGV) and the ratio of fibroglandular tissue to total breast volume (TBV), providing valuable insights for breast health assessment that are expected to drive market acceptance of related products.
- Strategic Company Direction: QT Imaging is committed to improving global health outcomes through innovative technologies, and the new FDA clearance will provide robust support for the commercialization and technological development of its breast imaging solutions, further solidifying its leadership position in the medical device industry.
See More
QT Imaging Appoints New Medical Advisor
- Appointment of Medical Advisor: QT Imaging has appointed Dr. Mary W. Yamashita as Medical Advisor, who will provide strategic guidance on clinical interpretation standards and structured reporting frameworks, aiming to enhance clinical integration and user experience of the company's technologies.
- Professional Background: Dr. Yamashita serves as Section Chief of Breast Imaging at USC and has extensive experience in breast cancer screening and diagnosis, having participated in multicenter clinical trials, thereby enhancing the company's expertise in breast health management.
- Driving Technological Innovation: Dr. Yamashita will advance the development of a radiation-free 3D breast imaging solution, focusing on improving screening accuracy and safety, aligning with the company's mission to expand access to safe and comfortable breast imaging.
- Commitment to Clinical Excellence: CEO Raluca Dinu emphasized that Dr. Yamashita's involvement will strengthen the company's scientific foundation and accelerate the adoption of best-in-class structured reporting practices, thereby improving diagnostic accuracy and workflow efficiency.
See More
QT Imaging Secures First CPT Code, Unlocking New Commercial Opportunities
- CPT Code Approval: QT Imaging's 3D quantitative transmission ultrasound imaging technology has received its first CPT code, X579T, approved by the American Medical Association, marking a significant milestone in clinical and commercial advancement, with an effective date of January 1, 2027, thereby opening new commercial opportunities with hospital accounts.
- Technology Validation: The approval of this CPT code not only validates QT Imaging's technology and clinical foundation but also significantly enhances its commercial strategy, particularly in potential collaborations with hospitals, which is expected to drive broader adoption and reimbursement of the technology.
- Market Expansion Plans: QT Imaging plans to work closely with clinical partners, professional societies, and regulatory stakeholders to advance the adoption of its technology and pursue additional CPT codes, aiming to increase market share and improve patient experience.
- Innovative Imaging Advantages: QT Imaging's system employs advanced ultrasound technology that is radiation-free and compression-free, providing quantitative, reproducible information particularly valuable for women with dense breast tissue, thereby enhancing overall patient experience and supporting better-informed clinical decision-making.
See More
QT Imaging Reports Q4 Loss but 2025 Revenue Surpasses Guidance
- Significant Revenue Growth: QT Imaging reported a revenue of $18.9 million for 2025, exceeding the company's guidance of $18 million and representing a remarkable 288% increase compared to 2024, indicating strong market performance and growth potential.
- Decline in Gross Margin: The gross margin for 2025 was 45%, down from 54% in 2024, primarily due to higher costs associated with two scanners built by a contract manufacturing partner, including tariffs and fees, which may impact future profitability.
- Improvement in Operating Expenses: Total operating expenses for 2025 were $13.0 million, a 12% improvement from $14.8 million in 2024, largely due to a $3.6 million decrease in professional fees, showcasing effective cost control measures by the company.
- Widening Net Loss: The net loss for 2025 was $21.1 million, significantly higher than the $9.0 million loss in 2024, primarily driven by non-cash expenses and increases in fair value liabilities, reflecting challenges in financial management.
See More
QT Imaging Reports Preliminary Financial Results for 2025
- Record Quarterly Revenue: QT Imaging achieved a record revenue of $8.275 million in Q4 2025, significantly up from $847,000 in the same quarter last year, indicating strong market demand and execution in breast health management.
- Annual Performance Exceeds Expectations: The company reported total revenue of $18.925 million for the full year 2025, surpassing its projections and reflecting a successful transition from a traditional scanner company to a SaaS and biomarker-driven medical imaging platform.
- 2026 Sales Outlook: QT Imaging anticipates approximately $39 million in revenue for 2026, including scanner shipments and initial SaaS Cloud Platform revenue, highlighting the strategic partnership with NXC Imaging and its potential to drive future growth.
- Investor Call Announcement: The company plans to hold an investment community conference call on March 23, 2026, following the filing of its Form 10-K for 2025, enhancing communication with investors and showcasing its future growth strategy and financial transparency.
See More
QT Imaging Reports Record $8.3 Million Revenue in Q4 2025
- Significant Revenue Growth: In Q4 2025, QT Imaging achieved record revenue of $8.3 million, representing a 97% increase from Q3 2025 and an impressive 877% year-over-year growth, highlighting strong market demand and execution in the medical imaging sector.
- Record Shipment Volume: The company shipped 17 QT Breast Acoustic CT™ scanners in Q4 2025, totaling 40 units for the year, a substantial increase from 12 units shipped in 2024, indicating enhanced market acceptance and sales capability of its products.
- Successful Nasdaq Relisting: QT Imaging successfully relisted on Nasdaq in less than a year after leaving the OTCQB market, demonstrating compliance in financial and corporate governance, which boosts investor confidence and enhances market visibility.
- Strategic Collaboration Expansion: The company entered into a strategic partnership with Intelerad Medical Systems, facilitating seamless integration of QT Imaging's cloud SaaS platform with Intelerad's secure cloud platform, further strengthening its competitive position in medical imaging solutions.
See More
QT Imaging Receives FDA Clearance for Enhanced Breast Imaging Technology
- FDA Approval for New Configuration: QT Imaging's Breast Acoustic CT™ scanner has received FDA 510(k) clearance for an updated configuration that enhances imaging coverage of breast tissue near the chest wall, significantly improving diagnostic capabilities and potentially strengthening the company's market position in breast health management.
- Technological Innovation: The new configuration optimizes the scanner's ability to image posterior breast tissue, an area often challenging to capture with standard methods, thereby enhancing overall diagnostic utility and addressing the market demand for high-precision breast imaging solutions.
- Enhanced Data Processing: The scanner generates both reflection-mode and transmission-mode ultrasound data to reconstruct 3D images and quantify fibroglandular tissue volume (FGV) and the ratio of fibroglandular tissue to total breast volume (TBV), providing valuable insights for breast health assessment that are expected to drive market acceptance of related products.
- Strategic Company Direction: QT Imaging is committed to improving global health outcomes through innovative technologies, and the new FDA clearance will provide robust support for the commercialization and technological development of its breast imaging solutions, further solidifying its leadership position in the medical device industry.
See More
QT Imaging Appoints New Medical Advisor
- Appointment of Medical Advisor: QT Imaging has appointed Dr. Mary W. Yamashita as Medical Advisor, who will provide strategic guidance on clinical interpretation standards and structured reporting frameworks, aiming to enhance clinical integration and user experience of the company's technologies.
- Professional Background: Dr. Yamashita serves as Section Chief of Breast Imaging at USC and has extensive experience in breast cancer screening and diagnosis, having participated in multicenter clinical trials, thereby enhancing the company's expertise in breast health management.
- Driving Technological Innovation: Dr. Yamashita will advance the development of a radiation-free 3D breast imaging solution, focusing on improving screening accuracy and safety, aligning with the company's mission to expand access to safe and comfortable breast imaging.
- Commitment to Clinical Excellence: CEO Raluca Dinu emphasized that Dr. Yamashita's involvement will strengthen the company's scientific foundation and accelerate the adoption of best-in-class structured reporting practices, thereby improving diagnostic accuracy and workflow efficiency.
See More
QT Imaging Secures First CPT Code, Unlocking New Commercial Opportunities
- CPT Code Approval: QT Imaging's 3D quantitative transmission ultrasound imaging technology has received its first CPT code, X579T, approved by the American Medical Association, marking a significant milestone in clinical and commercial advancement, with an effective date of January 1, 2027, thereby opening new commercial opportunities with hospital accounts.
- Technology Validation: The approval of this CPT code not only validates QT Imaging's technology and clinical foundation but also significantly enhances its commercial strategy, particularly in potential collaborations with hospitals, which is expected to drive broader adoption and reimbursement of the technology.
- Market Expansion Plans: QT Imaging plans to work closely with clinical partners, professional societies, and regulatory stakeholders to advance the adoption of its technology and pursue additional CPT codes, aiming to increase market share and improve patient experience.
- Innovative Imaging Advantages: QT Imaging's system employs advanced ultrasound technology that is radiation-free and compression-free, providing quantitative, reproducible information particularly valuable for women with dense breast tissue, thereby enhancing overall patient experience and supporting better-informed clinical decision-making.
See More
QT Imaging Reports Q4 Loss but 2025 Revenue Surpasses Guidance
- Significant Revenue Growth: QT Imaging reported a revenue of $18.9 million for 2025, exceeding the company's guidance of $18 million and representing a remarkable 288% increase compared to 2024, indicating strong market performance and growth potential.
- Decline in Gross Margin: The gross margin for 2025 was 45%, down from 54% in 2024, primarily due to higher costs associated with two scanners built by a contract manufacturing partner, including tariffs and fees, which may impact future profitability.
- Improvement in Operating Expenses: Total operating expenses for 2025 were $13.0 million, a 12% improvement from $14.8 million in 2024, largely due to a $3.6 million decrease in professional fees, showcasing effective cost control measures by the company.
- Widening Net Loss: The net loss for 2025 was $21.1 million, significantly higher than the $9.0 million loss in 2024, primarily driven by non-cash expenses and increases in fair value liabilities, reflecting challenges in financial management.
See More
QT Imaging Reports Preliminary Financial Results for 2025
- Record Quarterly Revenue: QT Imaging achieved a record revenue of $8.275 million in Q4 2025, significantly up from $847,000 in the same quarter last year, indicating strong market demand and execution in breast health management.
- Annual Performance Exceeds Expectations: The company reported total revenue of $18.925 million for the full year 2025, surpassing its projections and reflecting a successful transition from a traditional scanner company to a SaaS and biomarker-driven medical imaging platform.
- 2026 Sales Outlook: QT Imaging anticipates approximately $39 million in revenue for 2026, including scanner shipments and initial SaaS Cloud Platform revenue, highlighting the strategic partnership with NXC Imaging and its potential to drive future growth.
- Investor Call Announcement: The company plans to hold an investment community conference call on March 23, 2026, following the filing of its Form 10-K for 2025, enhancing communication with investors and showcasing its future growth strategy and financial transparency.
See More
QT Imaging Reports Record $8.3 Million Revenue in Q4 2025
- Significant Revenue Growth: In Q4 2025, QT Imaging achieved record revenue of $8.3 million, representing a 97% increase from Q3 2025 and an impressive 877% year-over-year growth, highlighting strong market demand and execution in the medical imaging sector.
- Record Shipment Volume: The company shipped 17 QT Breast Acoustic CT™ scanners in Q4 2025, totaling 40 units for the year, a substantial increase from 12 units shipped in 2024, indicating enhanced market acceptance and sales capability of its products.
- Successful Nasdaq Relisting: QT Imaging successfully relisted on Nasdaq in less than a year after leaving the OTCQB market, demonstrating compliance in financial and corporate governance, which boosts investor confidence and enhances market visibility.
- Strategic Collaboration Expansion: The company entered into a strategic partnership with Intelerad Medical Systems, facilitating seamless integration of QT Imaging's cloud SaaS platform with Intelerad's secure cloud platform, further strengthening its competitive position in medical imaging solutions.
See More
