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CE certificate for class IIa software medical device issued

A year of new achievements and new happiness started just perfectly with Cardiolyse finally receiving its CE and ISO certification papers!

We're certified as a standalone software medical device for automatic ECG interpretation, which now fully opens all the doors for sustainable commercial partnerships with hospitals, pharmacies, GP networks, and other digital health market disruptive players.

Within the certification process, Cardiolyse software and interpretation algorithms accuracy were proven with the 5 digital ECG records databases:

- AHA: The American Heart Association Database for Evaluation of Ventricular Arrhythmia Detectors

- MIT–BIH: The Massachusetts Institute of Technology – Beth Israel Hospital Arrhythmia Database

- ESC: The European Society of Cardiology ST-T Database

- NST: The Noise Stress Test Database

- CU: The Creighton University Sustained Ventricular Arrhythmia Database

We're excited about the upcoming super productive months of bringing value-added cardiac analytics products to more digital health providers in our mission of keeping more hearts healthy.

Stay tuned!

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