Lunit said on Monday that it has become the first software-as-a-medical-device (SaMD) company in the Asia-Pacific region to earn accreditations from the UK and Europe for its artificial intelligence (AI) medical solutions. ).
Lunit INSIGHT CXR and Lunit INSIGHT MMG, an AI solution for chest X-ray and mammography analysis respectively, have received CE marking under the latest European Medical Device Regulation (MDR) and UK Conformity Assessed ( UKCA).
According to the company, Lunit INSIGHT CXR, which received its first CE mark in 2019, is able to detect 10 chest abnormalities with 97-99% accuracy, including lung nodules, pulmonary fibrosis, pneumothorax and screening for tuberculosis. Subsequently, Lunit INSIGHT MMG, which detects breast cancer with 96% accuracy, received its first CE mark in 2020.
The European MDR, officially announced in May 2017, is the successor regulation to the existing Medical Device Directive (MDD), which imposes stricter guidelines on medical devices sold or exported to Europe.
However, MDR and UKCA certifications are mandatory for marketing in Europe and the UK, including devices already on the market. Failure to acquire MDR certification by May 2024 and UKCA certification by June 2024 will result in a ban on sale in Europe and the UK.
“Our MDR CE and UKCA certifications demonstrate Lunit’s high product power and advanced regulatory compliance capabilities,” said Lunit CEO Brandon Suh. “We will continue to react proactively to European market trends to accelerate our business expansion.”
In this regard, APAC Business Operations Manager of Medical Devices Division Regulatory Department Teruo Shingai at British Standards Institution (BSI) congratulated Lunit for being the first to achieve MDR CE and UKCA certification in the Asia-Pacific region.