Lunit Receives European Certification for AI Chest X-ray Diagnostic Solution

Lunit AI Chest X-ray Diagnostic Solution New Product 'Lunit Insight CXR4'. Photo by Lunit

On May 28, Lunit, a medical artificial intelligence (AI) company, announced that its new AI chest X-ray diagnostic solution, 'Lunit Insight CXR4,' has received certification under the European Medical Device Regulation (CE MDR).

The European CE MDR is a new integrated medical device regulation of the European Union (EU), which has been enforced since 2021 to strengthen the existing CE certification. Obtaining this certification means that Lunit has met the world's highest quality standards. Lunit Insight CXR4 was developed based on a large-scale dataset of 1.2 million images. By introducing three new core features that go beyond simple disease detection and focus on reading efficiency and patient safety, the product has advanced the technology level of AI chest diagnostics.

Lunit Insight CXR4 newly added a feature that automatically classifies normal cases. According to clinical trial results conducted during development, the accuracy (negative predictive value, NPV) for overall normal classification reached 99.5%, demonstrating high reliability.

The product includes a function that automatically compares a patient's past and current X-ray images. In particular, for nodule findings, which are key indicators of lung cancer, it automatically analyzes and presents differences with previous images, enabling medical professionals to intuitively assess changes in lesions and thereby improving diagnostic accuracy.

It also added a feature for detecting acute fractures of the ribs, clavicles, scapulae, and humeri, which are observable on chest X-rays. Acute fractures are among the findings that are easily missed during reading, but the new product quickly and accurately detects such lesions, providing enhanced support for decision-making in emergency situations and further strengthening patient safety. Lunit plans to expand product adoption to major hospitals and medical institutions across Europe, leveraging this certification.

In particular, as demand for early diagnosis of thoracic diseases such as lung cancer is high across Europe, Lunit Insight CXR4, now CE MDR certified, is evaluated as a highly competitive, high-precision AI solution. In addition, the company plans to begin full-scale commercialization in the domestic market alongside regulatory approval procedures. Lunit Insight CXR4 is positioned as a strategic product capable of completely replacing existing solutions and is expected to become a new standard for AI-based diagnostics within medical institutions in the future.

Seo Bumseok, CEO of Lunit, stated, "This new AI chest X-ray diagnostic product represents a significant advancement not only in reading efficiency and accuracy but also in ensuring patient safety," adding, "It will be particularly useful in medical institutions with a large backlog of unread images or in screening environments with a high proportion of normal cases."

This content was produced with the assistance of AI translation services.