South Korean artificial intelligence (AI)-powered cancer solutions provider Lunit has obtained CE marking for Lunit INSIGHT, its suite of AI solutions for radiology, under the latest Medical Device Regulation (MDR) of Europe.
The company has also secured the UK Conformity Assessed (UKCA) marking for its Lunit INSIGHT product line.
The two markings represent commercial approval for the products across both the UK and Europe.
Lunit has become the first software as a medical device (SaMD) company in the Asia Pacific region to obtain 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.”
Two products in the Lunit INSIGHT suite, Lunit INSIGHT CXR and Lunit INSIGHT MMG, received the CE marking under the MDR as well as the UKCA certifications.
Lunit INSIGHT CXR is an AI solution for chest x-ray analysis that has the capability to detect ten abnormal radiologic findings with 97% to 99% accuracy. It initially received CE marking in 2019.
The chest abnormalities include pneumothorax, pulmonary nodules, pulmonary fibrosis and tuberculosis screening support.
Lunit INSIGHT MMG is an AI solution for mammography analysis and has been designed for detecting suspicious lesions, which could be breast cancer, in mammograms with 96% accuracy.
It received its first CE marking in 2020.
Last November, the company raised $61m in its pre-IPO fundraising round, which was led by major global healthcare investors.