Level 3 plus
I am a CE-certified medical device
I am safely connected
I have proven my social-economic evidence and get reimbursed by NIHDI
I am safely connected
I have proven my social-economic evidence and get reimbursed by NIHDI
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General description
Additional info
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Financing
General description (provided by company)
Main purpose
FibriCheck is a medically certified application that registers heart rhythm disorders and associated symptoms by way of an app on your smartphone.
The user is given an access code from his/her care professional to use the app for a certain length of time. Simply placing your finger on the camera of your smartphone for 1 minute enables FibriCheck to carry out high quality measurements. These measurements are sent to your doctor in a detailed report that provides full insight into your heart health for relevant clinical actions to be taken as and when necessary.
In addition, users can also use FibriCheck for self-monitoring purposes without the supervision of a doctor.
The user is given an access code from his/her care professional to use the app for a certain length of time. Simply placing your finger on the camera of your smartphone for 1 minute enables FibriCheck to carry out high quality measurements. These measurements are sent to your doctor in a detailed report that provides full insight into your heart health for relevant clinical actions to be taken as and when necessary.
In addition, users can also use FibriCheck for self-monitoring purposes without the supervision of a doctor.
Target audience
FibriCheck can be used as part of care pathways where:
- the idea is to be able to effectively monitor patients who are recovering from an intervention or procedure to restore their heart rhythm so as to gain an understanding of the patient’s symptom-rhythm correlation.
- the idea is to detect new heart rhythm disorders, as is the case with patients who show symptoms that have yet to be categorised, or patients who have suffered a cryptogenic stroke and who require long-term monitoring.
- the idea is to be able to effectively monitor patients who are recovering from an intervention or procedure to restore their heart rhythm so as to gain an understanding of the patient’s symptom-rhythm correlation.
- the idea is to detect new heart rhythm disorders, as is the case with patients who show symptoms that have yet to be categorised, or patients who have suffered a cryptogenic stroke and who require long-term monitoring.
Approach
The FibriCheck application is strictly intended to register, render, save and transmit photoplethysmogram (PPG) data. Registrations are performed by having the skin contact the camera of a mobile device in order to detect volumetric changes.
Connectivity to sensors and platforms
FibriCheck does not connect to sensors and/or medical devices.
Financing and pricing model
A licence model for hospitals and care professionals. Please contact us at info@fibricheck.com to find out more.
Pathology
Heart / Blood Vessels
Functions
Alerts & Notifications
Diagnostics
Health Tracking
Remote Clinical Monitoring
Users
Men
Women
Elderly
Clinicians
Additional info
Compliance to M3 criteria
This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:
Compliance to M2 criteria
Reimbursement request
Submission date
04-10-2022
Evaluation date
16-01-2023
Evaluation result
Self declaration to 6 ICT criteria
Criterion 1: GDPR app category
Criterion 2: Identification of the user in need of care
Criterion 3: App user authentication
Criterion 4: Verification of therapeutic relationship and informed consent
Criterion 5: Applied interoperability standards
Criterion 6: GDPR compliance
Extra: Secured Messaging
Compliance to M1 criteria
CE certification
Certificate granted on 08/10/2019
Certificate valid till 31/12/2028
Class type of medical device (More info): 2A
ISO Standards:
FAMHP registration and notification
Company registration number at FAMHP: 61229
Product identification code at FAMHP: 7
General Data Protection Regulation (More info)
Reference publication
https://mhealth.jmir.org/2017/8/e129/
User instructions
Follow your doctor’s advice. As a standard routine, we recommend measuring your heart rhythm twice a day: once in the morning and once in the evening before turning in for the night. If you are experiencing symptoms, we recommend taking extra measurements as and when you experience them.
FibriCheck can be used any time, anywhere. The only thing you need is a smartphone and 1 minute of your time.
Even without an internet connection, you can still run measurements. In that case, your measurement result becomes available as soon as you are back online. This is due to the fact that the data need to be transmitted to our cloud environment to be analysed.
For further details, be sure to read our user instructions at https://pages.fibricheck.com/ifu/app/.
FibriCheck can be used any time, anywhere. The only thing you need is a smartphone and 1 minute of your time.
Even without an internet connection, you can still run measurements. In that case, your measurement result becomes available as soon as you are back online. This is due to the fact that the data need to be transmitted to our cloud environment to be analysed.
For further details, be sure to read our user instructions at https://pages.fibricheck.com/ifu/app/.
Components of the application
Native appWeb applicationWearable / SensorMedical deviceClient-server
Complaints handling
Via e-mail: support@fibricheck.com
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