Cardiolife receives EU MDR Certification

Digital Logic Kardio Software SA has successfully secured CE certification under the EU Medical Device Regulation (MDR) for Cardiolife, its AI-driven ECG analysis software. This regulatory milestone ensures compliance with the highest European standards for safety and clinical performance, allowing Cardiolife to be deployed across hospitals, clinics, and healthcare institutions throughout Europe.

"Achieving MDR certification is a significant milestone that reinforces our commitment to transforming cardiovascular diagnostics with AI," says CEO, Kristin Lied. "With this approval, Cardiolife is now positioned to support healthcare professionals across Europe, improving diagnostic consistency and efficiency."

Cardiovascular diseases remain the leading cause of death worldwide, and electrocardiograms (ECGs) are a critical tool in their diagnosis. However, variability in ECG interpretation can impact patient outcomes. Cardiolife addresses this challenge with a powerful, AI-driven solution that delivers precise, standardized, and automated ECG analysis.

Trained on over 1,2 million ECGs labeled by expert cardiologists, Cardiolife processes ECGs and Holters from any device, providing high-precision segmentation, analysis, and diagnostic interpretation. The software seamlessly integrates with hospital information systems making it easy for healthcare professionals to implement AI-driven diagnostics into their workflow.

Built on a cutting-edge neural network, Cardiolife provides automated detection of key ECG parameters with exceptional accuracy. In an independent, European wide clinical validation, Cardiolife demonstrated 99% balanced accuracy for critical cardiac diagnoses, including AFib, PVC, CRBB, LBBB, and LVLL. Covering 37 cardiac diagnosis/metrics, Cardiolife provides reliable and standardized ECG analysis, supporting clinicians to improve patient care and optimizing clinical workflows.

With MDR certification secured, Digital Logic Kardio Software SA is now preparing for further international expansion, with FDA clearance as the next major regulatory objective.

“With the global ECG market projected to reach $18 billion by 2030, Cardiolife is positioned to become a leading AI-powered ECG analysis platform, empowering healthcare providers with next-generation cardiac diagnostic tools” says Lied.

For further inquiries, please contact

Kristin Lied
CEO
+47-95128830
kl@cardiolife.global  
https://cardiolife.global