Lunit (KRX: 328130.KQ), a global provider of AI-enabled cancer solutions, today announced that its suite of AI solutions for radiology, Lunit INSIGHT, has received CE Marking under Europe’s latest Medical Devices Regulation (MDR). The Lunit INSIGHT range has also received the UK Conformity Assessed (UKCA) mark and commercial approval in both the UK and Europe.
With these two awards, Lunit is the first Software as a Medical Device (SaMD) company in Asia Pacific to receive such accreditation.
Under the Lunit INSIGHT suite, two products received 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 Mark in 2019, detects 10 breast abnormalities with 97-99% accuracy, including pulmonary nodules, pulmonary fibrosis, pneumothorax, and supports tuberculosis screening. Lunit INSIGHT MMG, which detects breast cancer with an accuracy of 96%, received its first CE mark in 2020.
Officially announced in May 2017, the European MDR is the successor regulation to the existing Medical Devices Directive (MDD), which imposes stricter guidelines on medical devices sold or exported to Europe.
The MDR and UKCA certifications are essential for commercialization in Europe and the UK as all commercial medical devices – including those already on the market – are required to receive the two marks. The implementation deadlines for the two certifications are set for May 2024 and June 2024 respectively.
“Our MDR CE and UKCA certifications clearly demonstrate Lunit’s high product performance and advanced regulatory compliance capabilities,” noted Brandon Suh, Lunit CEO. “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.”
