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Lunit highlights enterprise AI adoption and FDA-cleared advancements at SBI 2026
SEOUL, South Korea, April 16, 2026 /PRNewswire/ — At the Society of Breast Imaging (SBI) Annual Symposium, Lunit (KRX:328130), a leading provider of AI for cancer diagnostics and precision oncology, today announced accelerating clinical adoption across the U.S., a full-scale enterprise deployment of its AI-powered breast cancer ecosystem, and FDA clearance of its next-generation 3D mammography AI.
Lunit x Lexington Clinic
Lexington Clinic Adopts Full Breast Cancer Ecosystem
Lexington Clinic, Central Kentucky’s largest and oldest physician-owned multi-specialty medical group (serving more than 350 providers), has implemented Lunit’s complete AI-powered breast cancer ecosystem.
The deployment spans:
- Detection with Lunit INSIGHT® Breast Suite for mammography (MMG) and digital breast tomosynthesis (DBT)
- Quality optimization with Analytics™ and Volpara® Live™
- Volumetric breast density assessment with Volpara® Scorecard™
- Risk assessment with Risk Pathways™, integrated into clinical workflows
- Mammography tracking with Patient Hub™
The implementation signals a shift toward end-to-end AI integration across the breast care continuum—from risk to detection to quality—within a single software suite.
“Our goal is to deliver the highest standard of care while keeping workflows efficient and consistent,” said Angie Hall, Breast Center Manager at Lexington Clinic. “Bringing risk, detection, and quality into one ecosystem improves coordination across our team and supports more confident, earlier decision-making for every patient.”
Adoption Across the Americas Surpasses 330 Sites
Over the past year, Lunit has expanded to more than 330 screening sites across the Americas, supporting approximately one million screening mammograms annually.
The milestone highlights a broader industry shift: while AI validation is well established, real-world adoption at scale is now the key differentiator.
“Across the Americas, we’re seeing a clear move from evaluation to enterprise-wide implementation,” said Craig Hadfield, CEO of Lunit International. “Providers are moving beyond pilots into daily clinical use. Reaching more than 330 sites and supporting one million screenings annually reflects sustained, real-world adoption—where AI is delivering value in routine practice.”
Real-World Clinical Impact: Radiology Consultants of Iowa
At Radiology Consultants of Iowa (RCI), one of the largest radiology groups in the state, Lunit INSIGHT DBT is already embedded in routine clinical workflows, demonstrating the impact of AI beyond the study setting.
“After six months of using AI in our daily workflow, it’s become part of how we read,” said Robert J. Dolan, DO, breast imaging specialist at RCI. “It gives us added confidence—especially in subtle cases—and helps ensure we don’t miss what matters most.”
At SBI, Dr. Dolan will review cases each day in Lunit’s booth, highlighting where AI positively impacts his interpretation, giving attendees a chance to discuss real-world adoption.
FDA Clearance of Next-Generation 3D AI with Current-Prior Comparison
As providers move into routine AI use, flexibility in how algorithms are deployed is becoming increasingly important. Lunit announced that Version 1.2 of its 3D mammography algorithm has received clearance from the U.S. Food and Drug Administration (FDA).
The updated version introduces current-prior comparisons and multiple operating thresholds, enabling providers to tailor AI performance to their clinical environment.
Key enhancements include:
- Current-prior comparison (CPC) provides AI findings for the current exam and up to two prior exams
- Three selectable thresholds, supporting different sensitivity and specificity trade-offs
- Access to Volpara® Scorecard™ volumetric breast density measures along with AI scores
These updates reinforce Lunit’s focus on practical usability—giving clinicians greater control over how AI is applied in daily practice.
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About Lunit
Founded in 2013, Lunit (KRX: 328130) is a global leader on a mission to conquer cancer through AI. Our clinically validated solutions span medical imaging, breast health, and biomarker analysis—empowering earlier detection, smarter treatment decisions, and more precise outcomes across the cancer care continuum.
Lunit offers a comprehensive suite spanning risk prediction and early detection to precision oncology. Our FDA-cleared Lunit INSIGHT Breast Suite and breast health solutions support cancer screening in thousands of medical institutions worldwide, while the Lunit SCOPE platform is used in research partnership with global pharma and laboratory leaders for biomarker research, and companion diagnostic development.
Trusted by over 10,000 sites in more than 65 countries, Lunit combines deep medical expertise with continuously evolving datasets to deliver measurable impact—for patients, clinicians, and researchers alike. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at lunit.io.
