Medicalgorithmics Secures Health Canada Approval for DeepRhythmAI Algorithms, Expanding ECG Analysis Solutions in Key Market

Artificial intelligence algorithms DeepRhythmAI (DRAI), used for ECG data analysis, have obtained Health Canada registration for use in Canada. This is another regulatory approval – following US 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 ECG data analysis services.

DeepRhythmAI (DRAI) is an advanced set of artificial intelligence algorithms, designed to deliver fast and accurate results of ECG analysis, supporting the diagnosis of heart arrhythmias. The DRAI algorithms have been trained on data encompassing over 3.6 million days of ECG recordings, making them one of the most advanced solutions of this type in the world. The effectiveness of the technology was confirmed in the DRAI MARTINI study, presented at the start of September at the ESC Congress 2024 in London – Europe’s largest cardiology conference. The study, involving over 14 thousand patients and more than 50 cardiologists from the US, Canada, and Europe, showed that DRAI algorithms make 14 times fewer errors in ECG data analysis and identifying critical cases of heart arrhythmia than 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 pleased that Health Canada, responsible for certifying medical products, has issued a license for the new generation of our DeepRhythmAI algorithms. This will allow us to offer this solution to our Canadian users, which will contribute to improving the quality of services provided and, eventually, increase the number of users of our software – says Przemysław Tadla, Board Member and CTO of Medicalgorithmics.

Since 2018, m-Health Solutions, a company specializing in cardiac diagnostics and remote heart monitoring, has been a strategic partner for Medicalgorithmics in the Canadian market. In mid-2023, the parties expanded their cooperation: the Polish company delivered 300 fourth-generation PocketECG heart monitoring devices to Canada and integrated other partner devices with its own software and algorithms for cardiac diagnostics.

The Medicalgorithmics-developed cloud platform DeepRhythm Platform (DRP) is also in the process of being registered with Health Canada. Medicalgorithmics expects that after obtaining a license for DRAI, the regulator will quickly approve the DRP platform for use in Canada. This will allow the company’s Canadian partner to use the latest technology, which will strengthen Medicalgorithmics’ position and potentially accelerate revenue growth and the number of patients undergoing tests in Canada.

The DRAI algorithms combined with the DRP platform represent a new generation of Medicalgorithmics’ products, offering high performance, scalability, and security in diagnosing heart arrhythmia. In the first half of this year, the company completed the process of obtaining regulatory approvals for both solutions on the American and European markets. Medicalgorithmics offers DRAI algorithms as a standalone product or in combination with the DRP platform in the USA and Europe, allowing doctors and ECG technicians quick access to analysis results. Both solutions have already been successfully commercialized for the first customers.