Lunit Launches Enhanced Lunit INSIGHT CXR4, Secures CE MDR Certification for Expanded AI Capabilities

Next-generation AI solution introduces new clinical features and broader disease detection for chest X-rays

SEOUL, South Korea, May 28, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, today announced the official launch and CE certification under the Medical Device Regulation (MDR) of Lunit INSIGHT CXR4, its next-generation chest X-ray analysis solution.

Lunit INSIGHT CXR4 is a comprehensive AI solution for chest imaging, designed to support radiologists across a wide range of clinical scenarios. It leverages advanced AI to detect 12 types of chest abnormalities—including lung nodules, pneumonia, and pneumothorax—expanding its diagnostic capabilities to include additional findings such as acute bone fractures. Trained on large-scale real-world datasets, the upgraded solution delivers improved diagnostic accuracy while supporting early detection of critical diseases.

In addition to expanded disease detection, Lunit INSIGHT CXR4 introduces several new features designed to enhance clinical workflow and diagnostic support:

• Normal Flagging: While other solutions may flag cases as normal simply due to the absence of detectable findings, CXR4 takes a more advanced approach—leveraging an AI engine trained on over 1,200,000 chest X-rays to proactively identify and confirm truly normal cases. Backed by a high negative predictive value (NPV) of 99.5%, CXR4 can reliably distinguish low-risk exams. For these high-confidence normal cases, the system automatically generates structured reports, helping radiologists reduce reading time and streamline workflow without compromising diagnostic safety.
• Current-Prior Comparison: Compares a patient's current chest X-ray with previous images to detect disease progression or improvement over time—enabling more informed clinical decisions. The latest version also supports nodule comparisons, offering added value for lung cancer screening and follow-up evaluations.
• New Finding—Acute Bone Fracture Detection: Enables detection of recent traumatic fractures within the chest X-ray field of view. By identifying subtle fractures that are easy to miss, CXR4 helps reduce interpretation time and improve diagnostic accuracy, particularly in busy clinical environments.

With CE MDR certification, Lunit is now positioned to deploy INSIGHT CXR4 across Europe—offering enhanced diagnostic confidence and workflow efficiency for radiologists managing high imaging volumes.

"With Lunit INSIGHT CXR4, we've gone beyond expanding detection—we've focused on what truly helps clinicians in their day-to-day workflow," said Brandon Suh, CEO of Lunit. "Features like active normal flagging and current-prior comparison are designed to reduce reading time and improve triage confidence, especially in high-volume settings. CE MDR certification is a key step toward broader adoption, and we're committed to bringing CXR4 to more hospitals worldwide."

With CE MDR certification now in place, Lunit is preparing to pursue additional regulatory approvals to make CXR4 available in more regions. The company aims to further integrate its AI solutions into clinical workflows across diverse healthcare systems.

CE MDR is the EU's enhanced regulatory standard for medical devices, ensuring stricter standards for safety, performance, and clinical validation.

About Lunit

Founded in 2013, Lunit (KRX:328130.KQ) is a global leader in AI for cancer diagnostics and therapeutics. With a mission to conquer cancer through AI, Lunit develops AI-powered solutions for medical imaging and biomarker analysis to enable precise diagnosis and personalized treatment. Lunit's FDA-cleared Lunit INSIGHT suite supports cancer screening at over 4,800 medical institutions in more than 55 countries. Lunit clinical studies have been featured in top-tier journals—including The Lancet Digital Health and Journal of Clinical Oncology—and presented at major conferences such as ASCO and RSNA. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at lunit.io.

SOURCE Lunit