Lunit first SaMD in APAC region to secure CE mark and UKCA certification for AI-based radiology solution

pharmafile | November 23, 2022 | News story | Research and Development  

Lunit, a South Korean medical software company, has become the first software as a medical device (SaMD) company in the Asia-Pacific (APAC) region to receive MDR CE and UKCA certifications. These certifications are required for all medical devices across the UK and Europe.


The certifications were for their suite of AI solutions for radiology called Lunit INSIGHT, notably Lunit INSIGHT CXR and Lunit INSIGHT MMG, under Europe’s newest Medical Device Regulation (MDR).


Lunit INSIGHT CXR is an AI solution for chest x-ray analysis that detects ten chest abnormalities within 97-99% accuracy; it was initially granted CE marking in 2019. The chest abnormalities include pulmonary nodules, pulmonary fibrosis, and pneumothorax, and it can support tuberculosis screening.


Lunit INSIGHT MMG is an AI solution for mammography analysis which is intended to detect breast cancer with 96% accuracy. This received its first CE marking in 2020.


Lunit CEO Brandon Suh said: “Our MDR CE and UKCA certifications clearly show Lunit’s high product power and advanced regulatory compliance capabilities. We will continue our proactive response to European market trends to accelerate our business expansion.”


British Standards Institution (BSI) medical devices regulatory service APAC commercial operations director Teruo Shingai added: “We sincerely congratulate Lunit on its first MDR CE and UKCA certification.”


James Spargo

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