RP Co., Ltd. (CEO Kim Joong-hee) announced that its AI-based electrocardiogram (ECG) analysis solution “ECG Buddy” has obtained certification under the European Medical Device Regulation (CE MDR, Medical Device Regulation).

CE MDR is a certification system implemented by the European Union (EU) to verify the safety and performance of medical devices and is a mandatory requirement for selling medical devices in the European market. Compared with the previous CE MDD, requirements for clinical data and post-market surveillance have been significantly reinforced, making it one of the more difficult certifications to obtain in the industry.

ECG Buddy is a software medical device that supports clinicians’ interpretation by having AI analyze electrocardiogram images. It has obtained Class II approval (No. Jeheo24-1179) from the Ministry of Food and Drug Safety and has been designated as a new health technology with deferred evaluation, allowing non-reimbursed use.

Since its establishment in 2021, RP has focused on developing ECG-centered AI technology, and through this certification, it has secured the official requirement for entering the European market.

CEO Kim Joong-hee said, “This CE MDR certification means that the accuracy and safety of ECG Buddy have been officially verified under Europe’s stringent standards, marking an important milestone in creating a new standard in global healthcare,” adding, “Starting with Europe, we will drive tangible changes in clinical settings around the world.”

Popular News