The FDA has approved FibriCheck as a medical smartphone application to become the first FDA approved app for heart rhythm disorders that uses only an optical signal originating from a non-medical device such as a smartphone.
FibriCheck utilises the camera of a smartphone, or the optical sensors of a smartwatch, to detect heartbeats and
derive a heart rhythm. This technique is based on photoplethysmography or PPG for short. By using artificial
intelligence in combination with medical software, FibriCheck is able to carry out an accurate analysis of the heart
rhythm and informs the user and/or the physician about this condition.
The main purpose of FibriCheck is to detect atrial fibrillation, a disorder that affects 1 out of 4 adults and has a fivefold increase for having a cerebrovascular stroke. By using the FibriCheck technology, the user can timely detect
atrial fibrillation and correct therapy can be provided.
A unique filing for the FDA
The FibriCheck-filing was unique as it is the first time the FDA has approved a smartphone application to detect
heart rhythm disorders without using any external medical devices.
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 or ECG. FibriCheck succeeded in achieving equal accuracy results compared to a state-of-the-art external device that connects to a smartphone with 2 electrodes to record a single lead ECG.
Lars Grieten, CEO and co-founder, comments: “Receiving FDA clearance for a software-only application using
consumer devices was a difficult challenge and demonstrates the competence and the excellence of our team.
Having all knowledge in-house, it serves as a foundation to expand our product development roadmap beyond the
smartphone and look into continuous monitoring”
Because users receive a medical diagnosis, the FibriCheck smartphone applications needs to comply with the
strict regulatory guidelines provided for medical devices. In 2016 FibriCheck already received its European Class
IIa clearance and now with the FDA approval, it can access the American market. Earlier this year, FibriCheck
opened a satellite office in San Francisco to prepare for its market entry. Since then, several business
development activities have been set up to integrate its underlying technology in existing hardware platforms. This
is revolutionary since the FibriCheck software can convert a consumer device into a medical device. The start-up
expects that the FDA approval will facilitate these processes and hopes to bring its product to the US market in 2019.