"The Extra Horizon platform has played a key role in helping FibriCheck meet the strict compliance issues that apply to medical software and has allowed FibriCheck to stay ahead of the curve."
FibriCheck is a pioneering digital health app that enables users to quickly and simply check their heart rhythm with their smartphone and get immediate and actionable results. The app is medically certified and trusted by clinicians around the world.
Currently FibriCheck has over 700,000 users across 40 countries. More than 6 million PPG recordings have been made with the app, and more than 40,000 cases of arrhythmia have been detected — thereby helping to prevent strokes and save thousands of lives.
The challenge
The speed at which FibriCheck was developed and brought to market, and the app’s continuing fast pace of growth, required a solid, compliant foundation from day one. Scaling a Software as a Medical Device (SaMD) solution means managing complex technical domains — development, scaling, DevOps — while ensuring ongoing compliance with the varying regulatory requirements of different territories.
It’s essential to maintain full compliance with IEC 62304, GDPR, and the many other strict and complex regulations applicable to digital health solutions, all without slowing down product development or increasing investment risk.
Why Extra Horizon
Extra Horizon provided the entire backend infrastructure for the FibriCheck heart rhythm monitoring app, ensuring full compliance with the strict regulations applicable to digital health solutions.
By supplying a Medical Backend-as-a-Service built on IEC 62304-compliant cloud infrastructure and GDPR-safe data storage, Extra Horizon:
- Accelerated FibriCheck’s technological readiness — reducing time to market significantly
- Reduced investment risk — by taking on the majority of the regulatory compliance burden
- Enabled global scaling — providing a solid foundation that grows with the app and accommodates necessary changes along the way
- Kept FibriCheck ahead of the curve — creating a sophisticated medical solution that pushes the conventional boundaries of digital health
The result
FibriCheck is now one of the most widely used cardiac monitoring apps in the world — a true pioneer in digital health.
- 700,000+ users worldwide
- 40 countries reached globally
- 6 million+ PPG recordings processed
- 40,000+ arrhythmia cases detected, preventing strokes and saving lives