FibriCheck, an mHealth app developed by Belgian startup Qompium, has become the world’s first FDA approved app capable of detecting atrial fibrillation, and other heart rhythm disorders, using only an optical signal originating from a non-medical device such as a smartphone.
Atrial fibrillation is a disorder that affects one out of four adults and increases the likelihood of having a cerebrovascular stroke. By using the FibriCheck technology, the user can timely detect atrial fibrillation and ensure correct therapy is provided.
When using FibriCheck, the user is required to place one of their fingers on the smartphone’s camera for one minute. During this time the camera measures the light reflection caused by the blood that is flowing in the fingertip – which is based the photoplethysmography (PPG) technique – and then constructs a signal representing the pulse signal.
After each measurement the user is prompted to enter their symptoms – if any, and the data is sent to an online platform where AI ensures an accurate diagnosis of the heart rhythm. The data is then processed in such a way that it can be interpreted by a healthcare professional, and the diagnostic results are aggregated into a report which contains all the necessary information and a recommendation for a call to action, if any is needed.
In order to receive its FDA clearance, FibriCheck had to demonstrate its accuracy compared to traditional technology to detect heart rhythm disorders using an 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.
“Receiving FDA clearance for a software-only app using consumer devices was a difficult challenge and demonstrates the competence and the excellence of our team,” said CEO and Co-founder at Qompium, Lars Grieten.
“Having all this knowledge in-house serves as a foundation to expand our product development roadmap beyond the smartphone and look into continuous monitoring,” continued Grieten.
Currently, FibriCheck can only be used through the means of an access token/code issued by a healthcare organisation or provider. This enables clinical follow-up in a controllable way. Alternative modes of operation are currently being implemented.
FibriCheck already received its European Class IIa clearance in 2016, and now with the FDA clearance the startup expects to enter the US market in 2019.