AI-powered platform for arrhythmia detection gains FDA approval

“In recent years, we have conducted intensive R&D in the area of a new class of software and AI algorithms for heart arrhythmia diagnostics,” Medicalgorithmics Chief Technology Officer Przemysław Tadla said in a prepared statement. “We have achieved significant milestones related to this project, including FDA approval and CE certification for DRAI algorithms and CE certification for the DRP platform. We are now pleased to announce that we have FDA approval to introduce the DRP platform to the U.S. market. This is the final milestone that enables us to complete the technological transformation of our product offering in the area of arrhythmia diagnostics.”

“The positive FDA decision and the earlier completion of CE certification for the DeepRhythm Platform open up new business opportunities for us,” added Jarosław Jerzakowski, the company’s chief commercial officer. “Some current partners and potential clients have expressed interest in commercially using our solution and were waiting for the regulatory process to conclude. Particularly significant for us is the FDA approval, which will allow us to offer services based on the latest DeepRhythm Platform along with our newest DRAI AI algorithms in the strategically important U.S. market. We expect that with a richer and more competitive offering, we will accelerate revenue growth.”