FDA Approves New Version of Medicalgorithmics’ DeepRhythmAI – A breakthrough in arrhythmia diagnosis
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.
Successful Q1 for Medicalgorithmics.Service revenue in the U.S. up 329% YoY. 11 new contracts in the first five months of 2025.
The Warsaw Stock Exchange-listed medtech company is consistently and successfully executing its growth strategy. In the first quarter of 2025, Medicalgorithmics acquired 7 new major clients and entered new markets with its innovative services powered by advanced AI algorithms. Sales revenue amounted to PLN 6.8 million, marking a 6% year-over-year increase, and the number of examinations performed rose by 96% YoY. Revenue from services in the company’s key U.S. market surged by 329% YoY. Due to record-high interest in DRAI and DRP, Medicalgorithmics’ Management Board anticipates continued and steady revenue growth in the coming quarters. In just the first five months of 2025, the company has already signed 11 new contracts, including 4 in the U.S., compared to 13 total (with 5 in the U.S.) for all of 2024.