'ECG Buddy’ Receives European CE MDR Certification
<p>ARPI Inc. (CEO: Kim Joong-hee) announced that its AI-based electrocardiogram (ECG) analysis solution, <strong>“ECG Buddy,”</strong> has obtained certification under the European Medical Device Regulation (CE MDR).<br> </p><p>CE MDR is a regulatory framework implemented by the European Union to verify the safety and performance of medical devices. It is a <strong>mandatory requirement for selling medical devices in the European market</strong>. Compared to the previous CE MDD, the certification has significantly stricter requirements for clinical data and post-market surveillance, making it more difficult to obtain.<br> </p><p>ECG Buddy is a software medical device that uses AI to analyze ECG images and assist clinicians in interpretation. It has already received <strong>Class II approval from Korea’s Ministry of Food and Drug Safety</strong> and has been designated as a <strong>new medical technology under evaluation exemption</strong>, allowing it to be used as a non-reimbursed service.<br> </p><p>Since its founding in 2021, ARPI has focused on developing ECG-centered AI technologies. With this certification, the company has now secured the <strong>official requirements to enter the European market</strong>.<br> </p><p>CEO Kim Joong-hee stated: “This CE MDR certification officially validates the accuracy and safety of ECG Buddy under Europe’s rigorous standards. It marks an important milestone in creating a new global standard in healthcare. Starting with Europe, we will bring meaningful changes to clinical practice worldwide.”</p><p> </p><p style="margin-left:0.0px;"><a target="_blank" rel="noopener noreferrer" href="https://www.donga.com/news/Health/article/all/20260226/133428806/1">➡️<i><u> Read the full article</u> </i></a></p><p style="margin-left:0.0px;">Source: Dong-A Ilbo</p>