12th October 2019
Qompium, an EIT Health-backed start-up is ready to enter the American market after receiving US FDA approval for its FibriCheck app to screen for stroke risk and other health problems.
The news was announced 8 October 2018, just days after Bieke Van Gorp, Co-Founder and COO of Quompium, accepted an EIT Award recognising the innovative value of the app.
FibriCheck became the first FDA approved app to screen for heart rhythm disorders by using only an optical signal originating from a non-medical device such as a smartphone.
The company’s FibriCheck app remotely screens for atrial fibrillation simply by having patients put their finger on the camera of their smartphone. More than 10 million in Europe suffer from atrial fibrillation, which can lead to heart failure, kidney problems and heart disease, though the first symptom is often a stroke. FibriCheck received its European Class IIa clearance in 2016, and with the FDA clearance, it can access the American market, according to a press release from Qompium, which opened a satellite office in San Francisco to prepare for American sales.
“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,” said Lars Grieten (CEO and co-founder). Having all knowledge in-house, it serves as a foundation to expand our product development roadmap beyond the smartphone and look into continuous monitoring”
Just won the EIT Award
The good news about FDA approval for FibriCheck came shortly after COO Van Gorp accepted the prestigious EIT Venture Award, which comes €50 000 in development funds and Europe-wide recognition, at the 4 October 2018 INNOVEIT conference in Budapest. (Van Gorp is shown accepting the award in the photo above.)
Van Gorp and the FibriCheck team were among EIT Health winners to take three of the five awards that night. In all, five EIT Health nominees were among the finalists for the coveted awards recognising Europe’s top innovators.
“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 co-founder)