Medicalgorithmics, a leader in cardiac diagnostics powered by artificial intelligence, announces that its flagship solution, DeepRhythmAI (DRAI), has received FDA 510(k) clearance for the latest version of its set of artificial intelligence algorithms. This new version enables automated analysis of ECG signals using both two-lead and single-lead configurations (such as patches placed on the chest), providing physicians with an even more versatile and accurate tool to support arrhythmia detection. The approval comes during a period of dynamic expansion of the Polish medtech and growing interest in Medicalgorithmics’ innovative services, especially in the U.S. market, where the company has already signed two new contracts since the beginning of the year.
“This milestone marks a major step forward for our software. The new version of DeepRhythmAI not only enhances access to precise arrhythmia diagnostics but also integrates more seamlessly with ECG monitoring devices such as Holters and outpatient telemetry systems,” emphasized Przemysław Tadla, CTO of Medicalgorithmics S.A. “By leveraging advanced deep learning models, including CNN and transformer architectures, we are delivering a solution with unmatched sensitivity and performance in detecting critical heart rhythm disorders.”
DeepRhythmAI is a cloud-based, hardware-agnostic set of artificial intelligence algorithms designed to analyze ECG data from devices such as Holter monitors, event recorders, and outpatient telemetry systems. It can be integrated with any third-party software or medical device, offering healthcare solution providers the flexibility to incorporate DRAI’s cutting-edge arrhythmia detection into their own platforms. This flexibility unlocks new opportunities for telemedicine and at-home patient monitoring, supporting seamless interoperability and scalable deployment.
“The FDA’s confirmation that our set of artificial intelligence algorithms is safe and effective is a tremendous achievement for the entire team,” said Jarosław Jerzakowski, COO of Medicalgorithmics S.A. “This clearance, secured at an unprecedented pace, allows us to strengthen our presence in the U.S. and global markets, providing healthcare facilities with a tool that genuinely improves patient care. It’s also proof of our commitment to developing innovative solutions in cardiac diagnostics.”
The latest version of DRAI remains a supportive tool designed for use by qualified medical personnel. It does not replace a physician’s clinical decision but significantly enhances the process of analyzing ECG data—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,” concluded Przemysław Tadla.