Lunit becomes the first software as a medical device (SaMD) company in Asia-Pacific (APAC) region to receive MDR CE and UKCA certifications, which are required for all medical devices across Europe and the UK, before 2024
Lunit CEO Brandon Suh and BSI APAC regulatory service commercial operations director Teruo Shingai. (Credit: Lunit Inc.)
Lunit has received the CE mark for Lunit INSIGHT, its suite of AI solutions for radiology, under Europe’s newest Medical Device Regulation (MDR).
The South Korea-based medical software company also secured the UK Conformity Assessed (UKCA) marking for Lunit INSIGHT product line.
UKCA represents commercial approval for products across both the UK and Europe.
With the regulatory approvals, Lunit has become the first software as a medical device (SaMD) company in the Asia Pacific region to earn CE and UKCA certification.
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 said: “We sincerely congratulate Lunit on its first MDR CE and UKCA certification.”
Two products in the Lunit INSIGHT suite, Lunit INSIGHT CXR and Lunit INSIGHT MMG have received the MDR CE and UKCA certifications.
Lunit INSIGHT CXR is an AI solution for chest x-ray analysis that detects 10 chest abnormalities with 97-99% accuracy. It was initially granted CE marking in 2019.
The chest abnormalities include pulmonary nodules, pulmonary fibrosis, pneumothorax, as well as supporting tuberculosis screening.
Lunit INSIGHT MMG is an AI solution for mammography analysis, intended to detect breast cancer with 96% accuracy, and received its first CE marking in 2020.
Officially announced in May 2017, MDR is a regulation of the European Union on the clinical investigation and sale of medical devices for human use.
The MDR and UKCA certifications are essential for all medical devices in Europe and the UK, including those already in the market, before May and June 2024, respectively.
Earlier this year, Lunit received the CE-IVDD Mark for ‘Lunit SCOPE PD-L1 TPS’, an AI-based PD-L1 tumour proportion score (TPS) analyser.