Medicalgorithmics has announced obtaining FDA 510(k) clearance for the latest version of its flagship solution — the DeepRhythmAI (DRAI) artificial intelligence algorithm suite. The new version enables automatic analysis of ECG signals in both two-channel and single-channel configurations, the latter commonly used in the U.S. (e.g., patches placed on the chest), offering physicians an even more versatile and accurate tool to support the detection of cardiac arrhythmias. This clearance comes amid the dynamic expansion of the Polish medtech sector and growing interest in Medicalgorithmics’ innovative services, especially in the U.S. market, where the company has already signed two new agreements since the beginning of the year.
“This is a milestone in the development of our software. The new version of DeepRhythmAI not only increases the availability of precise arrhythmia diagnostics but also integrates even better with ECG monitoring devices such as Holters and ambulatory telemetry systems,” emphasizes Przemysław Tadla, CTO of Medicalgorithmics S.A. “The use of advanced deep learning models, including CNNs and transformer-based architectures, allows us to provide physicians with a tool of unmatched sensitivity and effectiveness in detecting the most significant cardiac rhythm disorders,” Tadla highlights.
DeepRhythmAI is a cloud-based, hardware-agnostic artificial intelligence algorithm suite designed to analyze ECG data from devices such as Holters, event recorders, and telemetry systems. It can be integrated with any software or medical device from other manufacturers, offering medical solution providers flexibility in implementing state-of-the-art arrhythmia diagnostics on their own platforms. This flexibility opens new opportunities for telemedicine and remote patient monitoring, supporting interoperability and scalable deployments.
“The FDA has confirmed that our AI algorithm suite is safe and effective — this is a tremendous success for the entire team,” comments Jarosław Jerzakowski, COO of Medicalgorithmics S.A. “This clearance, obtained at a record pace, allows us to further strengthen our position in the American and global markets by offering healthcare facilities a tool that genuinely improves patient care quality. It also demonstrates our commitment to developing innovative solutions in cardiac diagnostics,” adds Jerzakowski.
The latest version of DRAI remains a diagnostic support tool intended for qualified medical personnel. It does not replace clinical decisions made by physicians but significantly streamlines the ECG data analysis process—reducing the risk of missed diagnoses and increasing the efficiency of cardiology teams.
“This is another step toward more precise, scalable, and accessible arrhythmia diagnostics for patients worldwide,” concludes Przemysław Tadla.
