Lunit (KRX: 328130.KQ), a global provider of AI-powered cancer solutions, today announced that its AI solution suite for radiology, Lunit INSIGHT, has received the CE marking under Europe’s newest Medical Device Regulation (MDR). The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe.
With these two markings, Lunit has become the first software as a medical device (SaMD) company in the Asia Pacific region to earn such accreditation.
Among the Lunit INSIGHT suite, two products received the MDR CE and UKCA certifications: Lunit INSIGHT CXR, an AI solution for chest x-ray analysis, and Lunit INSIGHT MMG, an AI solution for mammography analysis.
Lunit INSIGHT CXR, which received its first CE marking in 2019, detects 10 chest abnormalities with 97-99% accuracy, including pulmonary nodules, pulmonary fibrosis, pneumothorax, as well as supporting tuberculosis screening. Lunit INSIGHT MMG, which detects breast cancer with 96% accuracy, received its first CE marking in 2020.
The European MDR, officially announced in May 2017, is the succeeding regulation of the existing Medical Device Directive (MDD), imposing more stringent guidelines on medical devices sold or exported into Europe.
The MDR and UKCA certifications are essential for commercialization in Europe and the UK, with all commercial medical devices—including those already in the market—required to obtain the two markings. Implementation deadlines for the two certifications are set to May 2024 and June 2024, respectively.
“Our MDR CE and UKCA certifications clearly show Lunit’s high product power and advanced regulatory compliance capabilities,” remarked Brandon Suh, CEO of Lunit. “We will continue our proactive response to European market trends to accelerate our business expansion.”
Teruo Shingai, APAC Commercial Operations Director of Regulatory Service (Medical Devices) at the British Standards Institution (BSI), commented, “We sincerely congratulate Lunit on its first MDR CE and UKCA certification.”