CardioSignal Rolls Out Its First MDR (Class IIb) App Release

Nov 24th, 2025

CardioSignal takes heart health monitoring to a higher standard with its latest update, now fully compliant as a Class IIb medical device under the European Medical Device Regulation (MDR). This update reinforces our continued focus on meeting regulatory standards and delivering high-quality results for detecting signs of atrial fibrillation.

What’s new in this update

• Each measurement checks the correct operation of your phone’s sensors to ensure reliable results.

• The Vitals section now focuses only on average heart rate and cardiogram, to keep the focus on our core medical device functionality.

• Visual refinements for improved accessibility and overall ease of use.

• Background sounds during the measurement have been removed, allowing you to enjoy quiet and calm measurements.

• Revised Instructions for Use, Terms of Use, and Privacy Policy.

• Updated minimum OS requirements for Android and iOS.

Alongside these updates, we’re launching CardioSignal Inside, a new SDK integration model that enables B2B partners to embed our CE-marked AFib detection directly into their own mobile applications. This provides a fast, compliant way to bring CardioSignal’s capabilities into an existing app, creating new partnership opportunities.

The European Medical Device Regulation (MDR) framework sets high standards of quality and safety. These improvements bring safety, greater reliability, seamless integration, and everyday usability to the forefront.

Update now and support your heart health with greater confidence, every day.