Lunit INSIGHT DBT

by Lunit  · Based in South Korea → — Conquer Cancer through AI
Oncology Radiology
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Regulatory Status Disclosed

Overview

Lunit INSIGHT DBT is an AI-powered mammography software designed to enhance lesion detection in digital breast tomosynthesis (DBT) exams. It assists radiologists in interpreting complex cases with greater precision and efficiency. The solution automatically analyzes DICOM images, providing visualization and quantitative estimation of malignant lesions. It assigns an abnormality score (0-100) to suspicious lesions and classifies them as masses (including asymmetries and distortions) or calcifications.

The AI-guided navigation helps radiologists navigate faster by automatically jumping to key slices, reducing manual scrolling and reading time. This seamless integration into PACS and viewers supports single and double-reading workflows, helping manage high case volumes and reduce radiologist fatigue.

Clinically validated, Lunit INSIGHT DBT has shown to improve radiologists’ diagnostic performance, decrease reading times, and increase reporting efficiency. It demonstrates consistent high performance across various breast types (fatty and dense breasts), races, and ethnicities, trained on diverse datasets from the US, UK, and Korea. The software also helps reduce false positives and unnecessary callbacks, leading to more confident reads and lower patient anxiety.

Lunit INSIGHT DBT is intended to be used concurrently by interpreting physicians as a computer-assisted detection and diagnosis (CADe/x) software, aiding in the detection and characterization of suspicious lesions for breast cancer. It is not intended as a replacement for a complete interpreting physician’s review or their clinical judgment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered lesion detection in DBT exams
  • Abnormality scoring (0-100) for suspicious lesions
  • Classification of lesions (masses, calcifications)
  • AI-guided navigation to key slices
  • Reduces reading time and radiologist fatigue
  • Consistent performance across breast types (fatty/dense) and ethnicities
  • Reduces false positives and unnecessary callbacks
  • Seamless integration into PACS and viewers
  • Displays analysis results in DICOM SR, DICOM SC, and GSPS
  • Supports single and double-reading workflows

Use Cases

  • Enhancing breast cancer detection in 3D mammography
  • Aiding radiologists in interpreting complex DBT cases
  • Improving diagnostic performance and accuracy
  • Reducing reading time and increasing reporting efficiency
  • Facilitating earlier detection of interval cancers
  • Reducing unnecessary patient recalls

What Physicians Need to Know

Key Capabilities
Lunit INSIGHT DBT is an AI-powered mammography software designed to enhance lesion detection in digital breast tomosynthesis (DBT) exams. It provides AI-guided navigation during image review, marks suspicious lesions with an abnormality score, and classifies them as masses or calcifications. The software also offers a prior comparison feature for analyzing against previous examinations.
Clinical Utility
The tool aims to improve diagnostic accuracy, reduce radiologist reading time, and decrease false positives and unnecessary recalls. Studies suggest it can increase radiologists' sensitivity and specificity, reduce reading time by an average of six seconds per case, and potentially lead to earlier detection of interval cancers.
Integration Options
Lunit INSIGHT DBT is built for seamless integration into PACS and viewers. It supports various integration types including DICOM SR, DICOM SC, GSPS, and In-App Viewer.
Compliance Status
Lunit INSIGHT DBT has received U.S. FDA 510(k) clearance (November 2023) and is CE-marked under Europe's Medical Device Regulation (EU MDR) since March 2023.
Pricing Model
While specific pricing details are not publicly disclosed, Lunit offers a 'SecondRead™ AI' model where providers can offer AI-enhanced screening to patients for an out-of-pocket fee.
User Experience
The software is designed to simplify slice selection, reduce manual scrolling through image stacks, and support single and double-reading workflows. It provides interpretable AI for decision support with clear markings and abnormality scores.
Support Quality
Lunit provides full program support, including training and marketing materials for its 'SecondRead™ AI' service.
Implementation Complexity
The tool is designed for seamless integration into existing PACS and reading workflows, aiming for effortless adoption without disrupting clinical practice.
Evidence Base
Lunit INSIGHT DBT is backed by numerous peer-reviewed publications and clinical studies. It has been evaluated across diverse datasets from the US, UK, and Korea, demonstrating consistent performance across breast types, races, and ethnicities. Studies have shown improvements in diagnostic accuracy and reductions in reading time.
Physician Tip

Lunit INSIGHT DBT can serve as a valuable adjunct for interpreting DBT exams, potentially improving diagnostic accuracy and reducing reading time. Pay attention to the AI-generated abnormality scores and lesion classifications (masses or calcifications) as decision support. The tool's ability to highlight key slices and compare with prior exams can streamline workflow. While AI can enhance detection, especially in dense breasts, radiologists should integrate AI findings with their clinical judgment and patient history.

Lunit INSIGHT DBT is designed for seamless integration with existing PACS and viewer systems, supporting DICOM SR, DICOM SC, GSPS, and In-App Viewer options. This flexibility aims to minimize disruption during implementation and facilitate its use within current radiology workflows.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentSeamless integration across modalities, PACS, and reading workflows. The AI engine is trained on DBT datasets from the United States and South Korea and is suitable for analysis of mammograms from various breast densities, ethnicities, and manufacturers (Hologic and GE devices).
Data ExportUnknown
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
SOC 2 No AI-estimated
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

Lunit INSIGHT DBT is an AI-powered solution designed to assist radiologists in detecting breast cancer in digital breast tomosynthesis (DBT) images. It aims to improve diagnostic accuracy, reduce reading times, and enhance workflow efficiency for healthcare professionals. The software analyzes DICOM images, identifies suspicious lesions, and provides quantitative estimations of malignancy, with reported high accuracy in detecting early-stage cancers.

Overall: Positive

Strengths

  • Improves radiologists' diagnostic performance and accuracy, especially in dense breasts.
  • Decreases reading times and increases reporting efficiency.
  • Reduces false positives and unnecessary recalls, leading to less patient anxiety.
  • Provides earlier detection of interval cancers.
  • Seamless integration with existing PACS and radiology workflows.
  • Consistent high performance across various breast types, races, and ethnicities.

Limitations

  • Some studies suggest a potential 'trust gap' where radiologists may be less likely to recall AI-flagged cases, even if they are more likely to be cancerous.
  • While generally positive, some reviews on G2 mention that enterprise-level solutions like Lunit can be expensive for smaller clinics.
  • No specific cons were found from physicians or healthcare IT reviews regarding the functionality or performance of Lunit INSIGHT DBT.
  • No relevant reviews or opinions were found on Reddit, G2 (specific to DBT), or Capterra that detailed significant drawbacks or negative experiences with Lunit INSIGHT DBT.

Based on reviews from: resovault.com, slashdot.org, blackfordanalysis.com, lunit.io, itnonline.com, prnewswire.com, fda.gov, g2.com, capterra.com, koreabiomed.com, incepto-medical.com

Last updated: 2026-10-30

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Press & Coverage

lunit.io
Lunit Nets FDA Nod for AI-Powered 3D Breast Tomosynthesis Solution, Lunit INSIGHT DBT
Lunit announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3D Breast Tomosynthesis (DBT) AI solution, Lunit INSIGHT DBT, marking a significant step for entry into the US breast screening market. This approval follows previous FDA clearances for Lunit's chest X-ray triage solution and AI-powered mammography analysis solution.
2023-11
lunit.io
Lunit Meets MDR CE Standards for 3D Breast Tomosynthesis AI Solution
Lunit announced that its AI solution for 3D Breast Tomosynthesis (DBT) analysis, Lunit INSIGHT DBT, has met the requirements of the CE marking under Europe's latest Medical Device Regulation (MDR). This certification is crucial for launching the product in the European market, with plans for a late March rollout.
2023-03
mobihealthnews.com
Lunit obtains new CE mark for AI DBT solution
South Korean medical AI company Lunit has received a CE mark under Europe's latest Medical Device Regulation for its AI software for digital breast tomosynthesis (DBT) analysis, Lunit INSIGHT DBT. The company plans to roll out the software in Europe by the end of March and seek US FDA approval in the third quarter of the year.
2023-03
axisimagingnews.com
FDA OK Lunit's 3D Breast Tomosynthesis AI Technology
Lunit has secured U.S. FDA 510(k) clearance for its 3D breast tomosynthesis (DBT) AI solution, Lunit Insight DBT, enabling its full entry into the U.S. breast screening market. The AI algorithm analyzes 3D images from DBT equipment, offering faster and more accurate breast cancer diagnoses compared to traditional 2D mammography.
2023-11
lunit.io
Akumin Selects Lunit INSIGHT DBT™ to Enhance Nationwide Breast Imaging Services
Akumin, a national leader in outpatient radiology and oncology services, has chosen Lunit INSIGHT DBT to enhance its breast imaging services. This AI-powered solution aims to improve workflow, accuracy, and confidence in breast cancer detection.
2025-08
itnonline.com
Lunit to Present Studies on AI Screening, DBT Performance, and Density-Driven Risk Modeling at RSNA 2025
Lunit will present 14 studies at RSNA 2025, covering screening mammography, digital breast tomosynthesis (DBT), breast density science, and risk modeling. New evidence from Massachusetts General Hospital will assess Lunit INSIGHT DBT's performance on screening DBT using 1,000 retrospective examinations.
2025-12
auntminnie.com
Akumin adopts Lunit's AI-based breast screening software
Outpatient radiology and oncology service provider Akumin has selected Lunit's Insight DBT breast screening software to enhance its breast imaging services. The AI-based tool analyzes digital breast tomosynthesis (DBT) images to improve the detection of early-stage cancers and reduce false positives.
2025-08
koreabiomed.com
Lunit Expands Global Reach with New Contracts in UK and US for AI-Powered Breast Cancer Screening Solutions
Lunit has signed contracts with healthcare providers in the U.K. and U.S., including GenesisCare UK, VA Tulsa, and DeTar Healthcare System, to supply its AI and digital solutions for breast cancer screening. These agreements include Lunit INSIGHT MMG and Lunit INSIGHT DBT to support the interpretation of 2D and 3D mammograms.
2026-08

Videos

Product demos, reviews, and walkthroughs for Lunit INSIGHT DBT.

View all on YouTube

Frequently Asked Questions

Lunit INSIGHT DBT is an AI-powered diagnostic support tool designed to enhance lesion detection in 3D mammography (tomosynthesis) exams. It analyzes DICOM images, providing heatmaps and abnormality scores for suspicious lesions, which helps radiologists interpret complex cases with greater precision, improve diagnostic accuracy, and identify subtle findings.
Lunit INSIGHT DBT has received CE marking under Europe's Medical Device Regulation (MDR) in March 2023, which is a stringent requirement for medical devices in the EU. Additionally, it received U.S. Food and Drug Administration (FDA) 510(k) clearance in November 2023, allowing its entry into the U.S. breast screening market.
While Lunit INSIGHT DBT demonstrates high accuracy, studies have indicated that its performance may be lower for non-invasive cancers and calcifications. It is also not intended as a replacement for a complete interpreting physician's review or their clinical judgment. The AI does not learn in real-time, and images from commercial sites are not used for retraining.
Lunit INSIGHT DBT is designed for seamless integration into clinical workflows, including compatibility with PACS and viewers. This integration allows for AI-guided navigation during image review, reduces reading time, simplifies slice selection, and supports both single and double-reading workflows without disrupting existing infrastructure.
While Lunit INSIGHT DBT focuses on 3D mammography analysis, other AI tools exist for cancer screening, including those for chest X-rays and 2D mammography. Some alternatives offer broader capabilities, such as flagging, prioritizing, and drafting across the entire radiological read for various modalities like X-ray, CT, and MRI, rather than focusing on a single screening algorithm on one modality.
Lunit INSIGHT DBT is offered under an enterprise pricing model, and specific pricing information requires contacting sales. There is no free plan or trial published. In some instances, patients can opt into AI-enhanced screening for an out-of-pocket fee, such as $20.
Lunit INSIGHT DBT has demonstrated high accuracy, with an overall AUC (Area Under the Curve) of 0.91 in a large retrospective study. It has been shown to increase breast cancer detection rates by up to 18% and reduce false positives by up to 14%. The AI is highly sensitive and specific, flagging only what is truly suspicious.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed Lunit INSIGHT DBT

Funded through the company that built this tool.

Mirae Asset Venture Investments
Corporate VC T2
Seoul, South Korea
$5M-$25M
Mirae Asset Venture Investments is the venture capital arm of Mirae Asset Financial Group, a major South Korean financial services firm. The…
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