The new generation of DeepRhythmAI (DRAI) artificial intelligence algorithms, used for analyzing ECG data, has obtained Health Canada registration for use in Canada. This is another regulatory approval—following the U.S. FDA and European CE certification—for the latest generation of AI algorithms developed by Medicalgorithmics. Canada is one of the key markets for the company, where it offers its services in ECG data analysis.
DeepRhythmAI (DRAI) is an advanced set of artificial intelligence algorithms designed to provide fast and precise ECG analysis results for diagnosing cardiac arrhythmias. The DRAI algorithms were trained on data comprising over 3.6 million days of ECG recordings, making them one of the most advanced solutions of their kind globally. The effectiveness of the technology was confirmed by the independent DRAI MARTINI scientific study, presented in early September at ESC Congress 2024 in London—the largest cardiology conference in Europe. The study, conducted on over 14,000 patients with participation from more than 50 cardiologists from the U.S., Canada, and Europe, found that DRAI algorithms make 14 times fewer errors in analyzing ECG data and identifying critical arrhythmia cases in patients compared to trained ECG technicians.
“Canada is one of the most important markets for Medicalgorithmics, where we have been offering our ECG data analysis products for many years. We are delighted that Health Canada, the regulatory body responsible for the certification of medical products, has issued a license for our new generation of DeepRhythmAI algorithms. This allows us to offer this solution to our Canadian users, which should contribute to improving the quality of services offered locally and ultimately increase the number of users of our software,” said Przemysław Tadla, Member of the Management Board and CTO of Medicalgorithmics.
Medicalgorithmics’ cloud-based platform, DeepRhythm Platform (DRP), is also under review by Health Canada. The company expects that following the DRAI license, the regulator will soon approve the latest DRP platform in Canada. This will allow Medicalgorithmics’ Canadian partner to use the company’s latest technology, strengthening the company’s position in this market and potentially accelerating revenue growth and the number of patients analyzed in Canada.
The set of DRAI algorithms, in combination with the DRP platform, represents a new generation of Medicalgorithmics’ products, providing high efficiency, scalability, and safety in arrhythmia diagnosis. In the first half of this year, the company completed the regulatory approval process for both solutions in the strategic U.S. and European markets. Medicalgorithmics provides DRAI algorithms to clients in the U.S. and Europe as a standalone product or in combination with the DRP cloud platform, through which doctors and ECG technicians can access analysis results. Both solutions have already been successfully commercialized with initial clients.
Since 2018, Medicalgorithmics’ strategic partner in the Canadian market has been m-Health Solutions, specializing in cardiac diagnostics and remote heart monitoring. In mid-2023, both parties expanded their collaboration: the Polish company supplied 300 fourth-generation PocketECG devices to Canada and integrated other partner devices with its own software and cardiac diagnostic algorithms.