With CardioDesk, evismo has successfully completed the CE conformity assessment process for its own software for the first time. The ECG analysis software is now CE-marked as a Class IIa medical device under the European Medical Device Regulation (EU MDR).
CardioDesk was developed to support cardiologists in analysing and interpreting long-term ECG recordings. The browser-based software combines automated detection of cardiac rhythm events with a clear presentation of ECG data and AI-assisted draft reports.
CE marking under Regulation (EU) 2017/745 confirms that CardioDesk meets the applicable safety and performance requirements for Class IIa medical devices.
For evismo, the successful conformity assessment marks an important step in the company's development: from a provider of digital diagnostic services to a company that develops its own medical technology and brings it to market in compliance with regulatory requirements.
With CardioDesk, evismo continues to expand its technological and medical expertise, laying the foundation for future innovations in cardiac diagnostics.
Discover evismo CardioDesk