Medtech
Lunit Becomes the First Medical Software Company in Asia-Pacific to Become MDR CE and UKCA Certified
Lunit, a global provider of AI-powered cancer solutions, announced that its AI solution suite for radiology, Lunit INSIGHT, has received the CE marking…
Lunit, a global provider of AI-powered cancer solutions, announced that its AI solution suite for radiology, Lunit INSIGHT, has received the CE marking under Europe’s newest Medical Device Regulation (MDR). The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe.
With these two markings, Lunit has become the first software as a medical device (SaMD) company in the Asia Pacific region to earn such accreditation.
Among the Lunit INSIGHT suite, two products received the 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.
Recommended AI: Top 10 Martech Platforms Every Marketing Team Love Having in their Stack
Lunit INSIGHT CXR, which received its first CE marking in 2019, detects 10 chest abnormalities with 97-99% accuracy, including pulmonary nodules, pulmonary fibrosis, pneumothorax, as well as supporting tuberculosis screening. Lunit INSIGHT MMG, which detects breast cancer with 96% accuracy, received its first CE marking in 2020.
The European MDR, officially announced in May 2017, is the succeeding regulation of the existing Medical Device Directive (MDD), imposing more stringent guidelines on medical devices sold or exported into Europe.
Recommended AI: Microsoft 365 Security Features Protect Business Data from Evolving Threats
The MDR and UKCA certifications are essential for commercialization in Europe and the UK, with all commercial medical devices—including those already in the market—required to obtain the two markings. Implementation deadlines for the two certifications are set to May 2024 and June 2024, respectively.
“Our MDR CE and UKCA certifications clearly show Lunit’s high product power and advanced regulatory compliance capabilities,” remarked Brandon Suh, CEO of Lunit. “We will continue our proactive response to European market trends to accelerate our business expansion.”
Recommended AI: Consider Your DOOH Buying Methods Wisely: Direct Sales vs. Programmatic Buying
[To share your insights with us, please write to sghosh@martechseries.com]
The post Lunit Becomes the First Medical Software Company in Asia-Pacific to Become MDR CE and UKCA Certified appeared first on AiThority.
ETF Talk: AI is ‘Big Generator’
Second nature comes alive Even if you close your eyes We exist through this strange device — Yes, “Big Generator” Artificial intelligence (AI) has…
Apple gets an appeals court win for its Apple Watch
Apple has at least a couple more weeks before it has to worry about another sales ban.
Federal court blocks ban on Apple Watches after Apple appeal
A federal appeals court has temporarily blocked a sweeping import ban on Apple’s latest smartwatches while the patent dispute winds its way through…
