FibriCheck's a-fib detection app scores 510(k) clearance, targets 2019 US launch

The app monitors heart rhythms via the smartphone's camera and uses AI to identify irregularities.
By Dave Muoio
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Last week FibriCheck announced that it received FDA 510(k) clearance for its app, which uses a smartphone’s camera and artificial intelligence to monitor for heart rhythm disorders. With this, the Belgian company expects to bring its product to the US market sometime in 2019.

To identify atrial fibrillation, FibriCheck monitors the user's heart rhythm via photoplethysmography. From there, an algorithm within the app analyzes its measurements to determine whether the user’s condition is cause for concern. Of note, the tool does not require any additional hardware to measure its users.

According to FibriCheck, FDA made the clearance decision based on data showing that the app achieved similar accuracy results to another diagnostic device that relied on a smartphone and a single lead ECG.

Why it matters

Millions of people living in the US are estimated to have atrial fibrillation, and the largely asymptomatic condition is more prevalent among those who are older. An easy-to-use, smartphone-based screen that does not require the purchase or operation of any additional hardware could potentially help many of these people either identify or manage their condition.

What’s the trend

Outside of academic projects, consumer-friendly atrial fibrillation detection tools often require additional hardware such as AliveCor’s Kardio Mobile smartphone-connected ECG, are housed within a smartwatch like Apple’s latest offering, or like Zio involve a wearable patch.

FibriCheck received EU clearance for its app back in 2016, and opened a satellite office in San Francisco earlier this year in preparation of its US push.

On the record

“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, CEO and cofounder of FibriCheck, 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”