The U.S. Food and Drug Administration (FDA) – a federal agency overseeing the market for drugs and medical devices – has approved Medicalgorithmics’ new cloud-based platform for arrhythmia diagnostics, the DeepRhythm Platform (DRP), for use in the USA. The platform integrates with the latest generation of proprietary artificial intelligence algorithms, DRAI. FDA approval allows for the commercial deployment of this new solution to clients in the U.S. market. This decision positions the company’s product offering among the world’s leading solutions, opens up new business opportunities, and enhances its competitive and technological edge in the arrhythmia diagnostics market.
DeepRhythm Platform (DRP) is a cloud-based platform utilizing the latest technologies, providing high performance, scalability, and security in heart arrhythmia diagnostics. Integrated with the new generation of DeepRhythmAI (DRAI) artificial intelligence algorithms, which are best in class, DRP offers high diagnostic efficiency and flexibility, allowing the analysis of data from various types of EKG recorders used worldwide for arrhythmia diagnostics. DRP and the new generation of DRAI algorithms are one of two strategic R&D projects undertaken by Medicalgorithmics.
“In recent years, we have conducted intensive R&D in the area of a new class of software and AI algorithms for heart arrhythmia diagnostics. We have achieved significant milestones related to this project, including FDA approval and CE certification for DRAI algorithms and CE certification for the DRP platform. We are now pleased to announce that we have FDA approval to introduce the DRP platform to the U.S. market. This is the final milestone that enables us to complete the technological transformation of our product offering in the area of arrhythmia diagnostics,” said Przemysław Tadla, CTO of Medicalgorithmics.
CTO emphasized that in designing the new DRP cloud software, the company utilized its twenty years of experience working with doctors, EKG technicians, and clients from around the world. “By integrating the DRP platform with DRAI artificial intelligence algorithms, the system offers the highest accuracy of analysis among solutions currently available on the market, as confirmed by scientific studies. Clinical effectiveness is a key element that builds doctors’ trust in the software, and the entirely new workflow allows them to perform tasks that were previously impossible due to excessive time requirements. Additionally, DRP increases the efficiency of EKG technicians’ work through new automation capabilities in the analysis and generation of diagnostic reports,” Tadla explained.
Medicalgorithmics will offer the new DRP diagnostic platform in the U.S. market, the European Union, and other countries where either FDA or CE certification forms the basis for local product approval for commercial use. Besides the FDA approval, the DRP platform also obtained CE certification at the beginning of 2024. The new generation of DeepRhythmAI (DRAI) algorithms, the analytical engine of the platform, also holds regulatory approvals in the USA and the EU. The DeepRhythmAI algorithms have been FDA-approved for use in the USA since 2022, and the CE certification process concluded in early June. Obtaining FDA approval and completing CE certification for the DRP platform fulfills one of the key objectives in developing a new product portfolio outlined in the company’s 2023-2026 strategy.
“The positive FDA decision and the earlier completion of CE certification for the DRP platform open up new business opportunities for us. Some current partners and potential clients have expressed interest in commercially using our solution and were waiting for the regulatory process to conclude. Particularly significant for us is the FDA approval, which will allow us to offer services based on the latest DRP platform along with our newest DRAI artificial intelligence algorithms in the strategically important U.S. market. We expect that with a richer and more competitive offering, we will accelerate revenue growth. We believe that our new clients will quickly see how our technology optimizes their operations, leading to greater business scalability, cost savings, and the provision of the highest quality services to healthcare facilities and patients themselves,” said Jarosław Jerzakowski, COO of Medicalgorithmics responsible for operations and sales.
In the next three years, the DRP platform is expected to replace the currently offered and used PCClient software in 22 countries. According to the strategy, since 2023, Medicalgorithmics has offered clients seeking only EKG data analysis algorithms access to proprietary DRAI artificial intelligence algorithms. In February 2024, the company announced the commercial implementation of AI algorithms for its first client in the USA.