Cardiovascular Business July 24, 2024
Michael Walter

FibriCheck, a Belgium-based healthcare technology company, has gained U.S. Food and Drug Administration (FDA) for its artificial intelligence-powered digital platform that uses smartphone cameras to obtain heart rhythm measurements.

FibriCheck’s technology requires a patient to place their finger over a smartphone camera for 60 seconds, with no additional devices required. The company’s algorithms then evaluate findings for signs of heart rhythm conditions such as atrial fibrillation (AFib).

This FDA clearance covers FibriCheck’s entire platform, including its AI algorithms, smartphone application and provider portal.

“Receiving FDA clearance for a software-only application using consumer devices was a difficult challenge, but it showcases the competence and excellence of our team,” Lars Grieten, FibriCheck’s CEO and co-founder, said in a statement. “This is just...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

Continue Reading

 
Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Medical Devices, Technology
Related Articles:
New Handheld Device Could Deliver Bedside Blood Test Results in Under an Hour
Duke, GE HealthCare expand AI hospital command center
Legacy medical devices keep regulators up at night
Former Apple Exec Launches New Ergonomic Accessories Brand
Regulatory Hurdles and Ethical Concerns in FDA Oversight of AI/ML Medical Devices

Share This Article