Lunit INSIGHT DBT

by Lunit  · Based in South Korea → — AI-Powered Software for Enhanced 3D Breast Tomosynthesis Interpretation
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

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud-based with PACS and viewer integration
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Lunit INSIGHT DBT received U.S. Food and Drug Administration (FDA) 510(k) clearance (K231470) on November 6, 2023, for its 3D Breast Tomosynthesis (DBT) AI solution. It is a computer-assisted detection and diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspicious lesions for breast cancer in DBT exams. Version 1.2 of the algorithm, introducing current-prior comparisons and multiple operating thresholds, received subsequent FDA clearance on April 16, 2026.
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

Lunit INSIGHT DBT is an AI-powered software designed to assist radiologists in detecting and characterizing suspicious lesions for breast cancer in digital breast tomosynthesis (DBT) exams. It aims to improve diagnostic performance, reduce reading times, and enhance the early detection of breast cancer, including interval cancers and those in dense breast tissue. The software is FDA-cleared and CE-certified, and has been clinically validated in various studies.

Overall: Positive

Strengths

  • Improved breast cancer detection rates, including earlier detection of interval cancers and in dense breasts.
  • Reduced reading times and increased reporting efficiency for radiologists.
  • Fewer false positives and callbacks, leading to reduced patient anxiety and more confident reads.
  • Consistent high performance across different breast types, races, and ethnicities.
  • Seamless integration into existing PACS and viewers.
  • Provides AI-guided navigation and abnormality scores for decision support.

Limitations

  • Some general concerns about AI replacing human radiologists have been noted in discussions, though Lunit INSIGHT DBT is intended as an assistive tool.
  • The product is not intended as a replacement for a complete interpreting physician's review or their clinical judgment.

Based on reviews from: Lunit.com, Blackford Analysis, BioSpace, Vertec Scientific SA, Digital Health Regulatory Needs Assessment, Akumin, The Imaging Wire, RSNA, accessdata.fda.gov, Slashdot, Radiology, Capterra

Last updated: 2026-07-19

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Press & Coverage

Lunit (via PR Newswire)
Lunit Nets FDA Nod for AI-Powered 3D Breast Tomosynthesis Solution, Lunit INSIGHT DBT
Lunit announced it received U.S. FDA 510(k) clearance for its AI-powered 3D Breast Tomosynthesis (DBT) solution, Lunit INSIGHT DBT, marking a significant step into the US breast screening market. This follows its CE-mark under Europe's latest Medical Device Regulation (EU MDR) in March 2023.
2023-11
KBR
Lunit receives approval for 3D breast tomosynthesis AI solution < Device/ICT < Article - KBR
Lunit obtained approval from the Ministry of Food and Drug Safety (MFDS) in Korea for its 3D breast tomosynthesis AI analysis solution, Lunit INSIGHT DBT, enabling broader use in breast cancer screening and diagnosis in Korea. The solution had previously received U.S. FDA premarket approval in November 2023 and has been adopted by leading U.S. imaging centers.
2025-05
Lunit (via PR Newswire)
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 more stringent than previous directives, ensuring higher performance and quality standards for medical devices in Europe.
2023-03
PR Newswire
Lunit to Highlight New AI Evidence in Cancer Screening and Breast 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, showcasing new evidence on Lunit INSIGHT DBT's performance. Research from Massachusetts General Hospital assessed AI performance on screening DBT, showing Lunit INSIGHT DBT correctly localized 84.4% of true-positive cancers.
2025-12
PR Newswire
Akumin Selects Lunit INSIGHT DBTu2122 to Enhance Nationwide Breast Imaging Services
Akumin, a national leader in outpatient radiology and oncology services, has chosen Lunit INSIGHT DBTu2122 to enhance its nationwide breast imaging services. This partnership aims to integrate advanced AI technology to improve workflow, accuracy, and confidence in breast cancer detection.
2025-08
PR Newswire
Lunit Surpasses 330+ Sites and 1M Annual Screenings as Breast Imaging AI Moves into Clinical Practice
Lunit announced accelerating clinical adoption across the U.S., with its AI-powered breast cancer ecosystem, including Lunit INSIGHT DBT, now implemented in over 330 sites and supporting one million annual screenings. This milestone highlights a shift towards real-world, enterprise-wide AI integration in breast care.
2026-04
Radiology (via News-Medical.net)
AI algorithm identifies one-third of missed breast cancers in DBT screenings
A study published in Radiology found that an AI algorithm, Lunit INSIGHT DBT, correctly localized nearly one-third of interval breast cancers that were previously undetected on screening DBT exams. This suggests the AI's potential to reduce the interval cancer rate and improve screening outcomes.
2025-07
Lunit (via PR Newswire)
Lunit Achieves Historic Milestone: 100 Peer-Reviewed Papers Published on Its AI Medical Imaging Suite
Lunit announced the publication of 100 peer-reviewed papers in SCI journals featuring its Lunit INSIGHT suite, including Lunit INSIGHT DBT, as of April 2024. These publications highlight the clinical safety, effectiveness, and efficiency of Lunit INSIGHT products in cancer diagnostics.
2024-05

Videos

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

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Frequently Asked Questions

Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software designed to be used concurrently by interpreting physicians to aid in detecting and characterizing suspicious lesions in digital breast tomosynthesis (DBT) exams. It integrates seamlessly into PACS and viewers, providing AI-guided navigation, abnormality scores, and lesion classification to enhance precision and potentially reduce reading time.
Lunit INSIGHT DBT has received U.S. Food and Drug Administration (FDA) 510(k) clearance in November 2023. It also holds CE-mark certification under Europe's Medical Device Regulation (EU MDR) since March 2023.
Lunit INSIGHT DBT is an auxiliary aid and not a replacement for a physician's complete review or clinical judgment. While trained on diverse datasets, one study noted decreased model performance for calcifications, which could be a limitation of the DBT modality itself, and observed more false positives for architectural distortion.
While Lunit INSIGHT DBT is a prominent solution, other companies offer AI-powered breast imaging tools. Some competitors in the broader AI breast imaging market include Fujifilm, Philips Healthcare, Sectra, CureMetrix, Zebra Medical Vision, DeepHealth, and Hologic (Quantra).
Specific pricing models for Lunit INSIGHT DBT are not publicly disclosed by the company. Generally, AI solutions for healthcare are licensed through various models, which can include per-study fees, subscription models, or enterprise-wide agreements, often depending on the volume and integration complexity.
Lunit INSIGHT DBT does not learn in real-time from commercial site images. The AI is trained using biopsy-proven data sourced through formal collaboration agreements, and images from commercial sites are retained only for the duration of processing and are not used for retraining.
Studies suggest Lunit INSIGHT DBT can improve radiologists' diagnostic performance by enhancing lesion detection and reducing reading times, especially for complex cases and dense breasts. It aims to reduce false positives and callbacks, and has shown potential in earlier detection of interval cancers.

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Suggest an Edit → | 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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