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

AMI READMITS Score Predicts Heart Attack Patients at High Readmission Risk
News | Cardiac Diagnostics | October 09, 2018
Tracking just seven factors of heart attack patients when they are first admitted to the hospital can help flag those...
Siemens Healthineers Showcases New In Vivo and In Vitro Cardiovascular Solutions at TCT 2018
News | Cardiac Diagnostics | September 21, 2018
At the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept. 21-25 in San Diego, Siemens Healthineers...
Weight Loss Drug Does Not Increase Cardiovascular Events
News | Cardiac Diagnostics | August 31, 2018
A weight loss drug does not increase cardiovascular events, according to late breaking results from the CAMELLIA-TIMI...
Acarix Presents CADScor System at ESC 2018
News | Cardiac Diagnostics | August 27, 2018
Acarix AB’s ultra-sensitive acoustic CADScor System for coronary artery disease risk assessment will be on display at...
NIH Ending Funding for Moderate Alcohol and Cardiovascular Health Trial
News | Cardiac Diagnostics | August 24, 2018
The National Institutes of Health announced in June it plans to end funding to the Moderate Alcohol and Cardiovascular...
Study Shows Multiple Benefits of Patient-to-Patient Connectivity in Familial Chylomicronemia Syndrome
News | Cardiac Diagnostics | August 07, 2018
Akcea Therapeutics Inc., an affiliate of Ionis Pharmaceuticals Inc., announced the publication of results from the...
Being Overweight May Change Young Adults' Heart Structure, Function
News | Cardiac Diagnostics | August 03, 2018
Even as a young adult, being overweight may cause higher blood pressure and thicken heart muscle, setting the stage for...
High Intensity Exercise in Teenagers Could Ward Off Heart Disease

Ultrasound image of the carotid artery. Lines in yellow were used to determine arterial diameter and stretching before and following exercise.

News | Cardiac Diagnostics | July 16, 2018
New research published in Experimental Physiology has indicated potential differences in heart health benefits of...
News | Cardiac Diagnostics | June 14, 2018
A team of researchers says it has linked sensitivity to an allergen in red meat to the buildup of plaque in the...
Overlay Init