artificial intelligence robot evaluates healthcare data. Novo Nordisk announced a new collaboration with Valo Health, a healthcare technology company focused on using artificial intelligence (AI) technology to identify new drug treatments for cardiovascular disease (CVD).
Medicalgorithmics, a Polish healthcare technology company focused on using advanced artificial intelligence (AI) models to diagnose arrhythmias, has received approval from the U.S. Food and Drug Administration (FDA) for its new cloud-based DeepRhythm Platform.
The DeepRhythm Platform uses the company’s newest DeepRhythm AI (DRAI) algorithms—which first gained FDA approval in 2022—to evaluate electrocardiograms and deliver a warning when it identifies signs of cardiac arrhythmias such as atrial fibrillation. The platform also gained CE mark approval in 2024, ensuring it will be made available to healthcare providers in Europe in addition to those in the United States.
“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.”
