October 13, 2023 — The newly MDR-certified Cardiomatics solution is accurate, fast and easy-to-use AI-based standalone software for ECG analysis. The Cardiomatics ECG interpretation platform is used by more than 200 clinics and 1,000 medical professionals. The platform has shown how clinical-grade and validated AI can be used to automate the ECG analysis workflow allowing medical professionals to save hours per day and focus on clinical decisions.
The Medical Device Regulation (MDR) is the EU's most recent and comprehensive framework for the approval of medical devices. These stricter requirements were introduced to improve the quality, safety and reliability of medical devices, strengthen transparency and information for patients and enhance vigilance and market surveillance.
"Cardiomatics makes diagnostics much faster and more productive. This innovative AI-based ECG interpretation platform is MDR-certified now - we can be sure of quality, precision, and commitment to patient well-being" - underlines Prof. Dr. David Duncker, Electrophysiologist, Head of Hannover Heart Rhythm Center, Chair #EHRA_ESC Digital and E-Communication Committee and Cardiomatics Scientific Board Member.
Obtaining the MDR certification positions Cadiomatics well to continue expanding the use of its unique AI platform across Europe.
Empowering cardiac healthcare with new functionalities
In the newest v5 of the standalone software, Cardiomatics has implemented a major feature: Atrioventricular block detection of 2nd and 3rd degrees. Detecting AV blocks in ECG signals is vital for diagnosing and managing heart rhythm disorders, assessing patient risk, guiding treatment decisions, and providing valuable prognostic information. Apart from AV block detection, Cardiomatics now includes fast-track analysis and a new layout that allows medical professionals to review the detailed findings from the Cardiomatics analysis faster.
"Cardiomatics' achievement of the introduction of AV block detection in Cardiomatics v.5 and the world’s first MDR Certification for AI-based ECG interpretation mark the next pivotal moment for our company. We are confident that these advancements will empower healthcare professionals with the most precise and insightful tools for heart rhythm disorder diagnostics and treatment decisions." - says Rafał Samborski, CEO of Cardiomatics.
For more information: www.cardiomatics.co
May 13, 2026 
