2 weeks Ago By Jung So-yeon
The medical AI company CorelineSoft announced on the 28th that it has simultaneously received European CE MDR (Medical Device Regulation) and UKCA (UK Conformity Assessed) certification. This marks the first time an AI medical device software has been certified as Class IIb, and the first instance in Korea for diagnostic purposes. CorelineSoft has thus strengthened its position in the European market, including the new UKCA certification for the post-Brexit UK.
CE-MDR certification is a mandatory requirement for exporting medical devices to the EU market and replaced the existing MDD (Medical Device Directive) in May 2021. Unlike before, it is legally binding and provides greater assurance through more rigorous assessment procedures, management, control, and post-audit compared to the existing CE MDD certification, enhancing product safety and quality systems. With the acquisition of MDR, CorelineSoft can now sell its AI product line 'AVIEW' throughout Europe, including the 27 EU member states.
The CE MDR certification is significant as it is the first Class IIb certification for diagnostic medical AI software, indicating that CorelineSoft's AVIEW AI-based product line has ensured stability and high reliability within Europe. The certified products include AVIEW's Lung Nodule Automated Analysis Software 'AVIEW LCS', Chronic Obstructive Pulmonary Disease (COPD) Automated Analysis Software 'AVIEW COPD', Coronary Artery Calcium Automated Diagnosis Software 'AVIEW CAC', and other thoracic products, as well as AVIEW Brain's Intracerebral Hemorrhage Diagnostic Support Software 'AVIEW NeuroCAD' and Cerebrovascular Imaging Visualization Software 'AVIEW BAS'. CorelineSoft plans to use this certification to strengthen its marketing activities in the European market.
The focus will be on promoting the experience, quality, and safety of its AI software specializing in lung cancer screening. Dr. Jinkook Kim, CEO of CorelineSoft, said, "Obtaining CE MDR and UKCA certifications proves the high reliability and quality of CorelineSoft's medical AI in the European market," adding, "We will further accelerate our lung cancer screening projects, which are progressing rapidly in major European countries.
" Additionally, CorelineSoft received a positive response from European medical professionals during a webinar held on the 24th, in collaboration with European KOLs, on the role of AI software in German lung cancer screening. This indicates that CorelineSoft's technology is recognized in the European market and demonstrates its growth potential in the field of medical AI. The 'European Certification Ceremony', held on the 25th at CorelineSoft's headquarters in Seoul, was attended by CEO Seonghwan Im of the global international certification body, BSI, who graced the occasion.
CEO Jinkook Kim and CEO Seonghwan Im took commemorative photos with the certification, expressing their ambition to enter the European market..
