FibriCheck

By Qompium

FibriCheck is a software that determines heart rhythm conditions, with a primarily focus on the detection of Atrial Fibrillation.

Level 1

I am a CE-certified medical device

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Languages

DE EN ES FR IT NL
General description
Additional info
Media

General description

Main purpose

FibriCheck is a software that determines heart rhythm conditions, with a primary focus on the detection of Atrial Fibrillation.

Target audience

Adults with known or suspected heart conditions such as Atrial Fibrillation can use the FibriCheck application daily, or whenever feeling symptoms, to record their pulse waveform and to monitor their heart rhythm.

Approach

The FibriCheck application is only intended to record, display, store and transmit photoplethysmogram (PPG) data. Recordings are performed by making contact between the skin and camera of a mobile device or by skin and sensor of a wearable device. This way, volumetric changes can be detected.

Connectivity to sensors and platforms

FibriCheck does not connect to sensors and/or medical devices.

Financing and pricing model

All information about our pricing model can be found on our website: fibricheck.com

Pathology

Heart / Blood Vessels

Functions

Alerts & Notifications Diagnostics Health Tracking Remote Clinical Monitoring

Users

Men Women Elderly Clinicians

Additional info

Reference publication

https://mhealth.jmir.org/2017/8/e129/

User instructions

For good results and follow-up, we recommend performing at least 2 measurements a day and additional measurements when experiencing symptoms.

FibriCheck can be used anytime and anywhere as long as it is used on a compatible, functioning mobile or wearable device with sufficient battery. If there is no internet connection, a measurement can still be performed, but the measurement analysis will only be available after the connection has been restored as the information must be sent to the cloud for proper analysis.

More info: https://pages.fibricheck.com/ifu/app/

Components of the application

Native appWeb applicationWebsiteWearable / SensorMedical deviceClient-server

Self declaration

GDPR CompliantThe data is stored in EU only

ISO Standards

ISO 13485 Quality Management Systems for Medical Devices (on company level)ISO 14155 Clinical Investigations of Medical Devices in Human SubjectsISO 14971 Risk Management of Medical DevicesISO 62304 Medical Device Software Lifecycle ProcessesISO 62366 Application of Usability Engineering to Medical Devices

Class type

2A

FAMHP registration number

61229

FAMHP product identification code

7

Complaints handling

Media

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