FibriCheck heart monitoring app earns FDA approval
A Belgian company’s heart monitor smartphone application was recently approved by the Food and Drug Administration (FDA).
The FDA announced it granted market clearance to Qompium for its FibriCheck phone app, which is expected to launch in the U.S. market in 2019.
The app is designed to detect atrial fibrillation in its users, which could help them seek corrective therapy if necessary. The app uses a technique called photoplethysmography, utilizing a smartphone camera or optical sensors on a smartwatch to detect a user’s heartbeats and find heart rhythm.
“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 company stated in a press release.
FibriCheck is the first FDA-approved app for heart rhythm disorders that uses only an optical signal originating from a non-medical device, like a smartphone, according to the company.
“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, Qompium chief executive officer and co-founder, said in a statement. “Having all knowledge in-house, it serves as a foundation to expand our product development roadmap beyond the smartphone and look into continuous monitoring."
Danielle covers Clinical Innovation & Technology as a senior news writer for TriMed Media. Previously, she worked as a news reporter in northeast Missouri and earned a journalism degree from the University of Illinois at Urbana-Champaign. She's also a huge fan of the Chicago Cubs, Bears and Bulls.