Lunit INSIGHT CXR and Lunit INSIGHT MMG have received the CE marking and UKCA certifications. Credit: Lunit Inc.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.