FDA OKs Stand-Alone mHealth App For Detecting Heart Rhythm Disorders
The FDA has granted market clearance to the FibriCheck mHealth app, which measures heart rhythm via a smartphone camera or smartwatch sensors and can be used to detect atrial fibrillation.
The U.S. Food and Drug Administration recently granted market clearance for FibriCheck, a Belgium-based company whose mobile health app uses a smartphone camera or smartwatch sensors to measure one’s heartbeat. The process, called photoplethysmography, measures light reflection through blood flow.
FDA officials said this is the first approved mHealth app that detects heart rhythm disorders using only an optical signal originating from a non-medical device.
“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,” Lars Grieten, the company’s CEO and cofounder, said in a press release. “Having all knowledge in-house, it serves as a foundation to expand our product development roadmap beyond the smartphone and look into continuous monitoring.”
Available only in Europe, the FibriCheck app creates a pulse signal for the user, then requires the user to fill out an online questionnaire listing any other symptoms. That data is processed and sent back to the user and, if so desired, to a healthcare provider.
The app is available only through prescription by a healthcare provider, who issues a code or access token to the patient.
Company officials expect to begin marketing the app in the US in 2019.
To receive FDA approval, company officials tested their app alongside Alivecor’s KardiaBand mHealth wearable and an oximeter developed by Nonin, both of which record a single-lead ECG for analysis.
Fibricheck joins a growing number of connected health companies aiming to improve detection of cardiac issues through wearable devices that can be prescribed by a doctor or even purchased by the consumer.
While companies like AliveCor and BioSig Technologies are pairing their devices with clinical support, Apple recently tossed a wrench into the works by including an electrocardiogram sensor in its new Apple Watch Series 4, enabling users to track their heart rate and, if they want, send a snapshot to their care provider.