Technology | Mobile Devices | October 08, 2018

FibriCheck Receives FDA Clearance for Digital Heart Rhythm Monitor

Smartphone-only application detects heart rhythm disorders with the touch of a finger

FibriCheck Receives FDA Clearance for Digital Heart Rhythm Monitor
Smartphone-only application detects heart rhythm disorders with the touch of a finger

October 8, 2018 – The U.S. Food and Drug Administration (FDA) granted market clearance for FibriCheck, a Belgian medical smartphone application for the detection of heart rhythm disorders. The approval makes FibriCheck the first-FDA approved mobile app for heart rhythm disorders by using only an optical signal originating from a non-medical device such as a smartphone.

FibriCheck utilizes the camera of a smartphone or the optical sensors of a smartwatch to detect heartbeats and deriving a heart rhythm, a technique based on photoplethysmography (PPG). The user needs to place the finger for 1 minute on the camera of the smartphone. The camera will then measure the light reflection caused by the blood that is flowing in the fingertip (this is the principle of photoplethysmography). Based on this, a signal is constructed which represents the pulse signal. After each measurement the user is prompted to enter his symptoms (if any) and the data is sent to an online platform where artificial intelligence ensures an accurate diagnosis of the heart rhythm. Next, these data are processed in such a way they can be interpreted by a healthcare professional or a remote monitoring center. Finally, the diagnostic results are aggregated into a report which contains all the necessary information and a recommendation for a call to action if needed.

Currently, FibriCheck can only be used through the means of an access token/code issued by a healthcare organization or provider. This enables clinical follow-up in a controllable way. Alternative modes of operation are currently being implemented.

The main purpose of FibriCheck is to detect atrial fibrillation, a disorder that affects 1 out of 4 adults and has a five-fold increase for having a cerebrovascular stroke. By using the FibriCheck technology, the user can timely detect atrial fibrillation and correct therapy can be provided.

In order to receive its FDA clearance, FibriCheck had to demonstrate its accuracy compared to traditional technology to detect these heart rhythm disorders using an electrocardiogram (ECG). FibriCheck succeeded in achieving equal accuracy results compared to a state-of-the-art external device that connects to a smartphone with two electrodes to record a single-lead ECG.

FibriCheck received European Class IIa clearance in 2016. The application is expected to reach the U.S. market in 2019.

For more information: www.fibricheck.com

Related Content

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a costly tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. Amyloidosis Patient Registry  #Amyloidosis

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. This is Figure 2, showing how SPECT imaging allows the reader to distinguish between blood pool activity (ventricular cavity, etc) and myocardial activity and identify regional myocardial differences in radiotracer uptake.

News | Cardiac Diagnostics | March 05, 2020
March 5, 2020 — More than 300 patients have joined the Amyloidosis Patient Registry and it is now available to the en
heart disease image
News | Cardiac Diagnostics | December 18, 2019
December 18, 2019 — In their latest report, “...
FDA Warns Troponin Tests Impacted by Biotin Dietary Supplement
Feature | Cardiac Diagnostics | November 05, 2019 | Dave Fornell, Editor
November 5, 2019 — The U.S.
Videos | Cardiac Diagnostics | October 29, 2019
Doctor Clyde Yancy was a keynote speaker and said doctors need to check their assumptions about patients at the door...
79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event

79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event. Image courtesy of University Hospitals.

News | Cardiac Diagnostics | October 16, 2019
Health and wellness screenings are more than just nice events for the community – they can save lives. A Mentor, Ohio,...
Pesticide Exposure May Increase Heart Disease and Stroke Risk

Image courtesy of zefe wu from Pixabay

News | Cardiac Diagnostics | October 15, 2019
On-the-job exposure to high levels of pesticides raised the risk of heart disease and stroke in a generally healthy...
World Heart Federation Launches Global Roadmap on Cardiovascular Disease Prevention Among Diabetics
News | Cardiac Diagnostics | September 04, 2019
At the European Society of Cardiology (ESC) Congress 2019 together with the World Congress of Cardiology, the World...
Insomnia Tied to Higher Risk of Heart Disease and Stroke

Image courtesy of the American Heart Association

News | Cardiac Diagnostics | August 19, 2019
People suffering from insomnia may have an increased risk of coronary artery disease, heart failure and stroke,...