Current Report No: 15/2024
Date: 24.06.2024 r.
Legal Basis: Article 17, Section 1 of the MAR Regulation – Confidential Information
The Management Board of Medicalgorithmics S.A., based in Warsaw, Poland “Company” informs that the US Food and Drug Administration FDA has granted approval for the Company’s new diagnostic platform: DeepRhythm Platform DRP to be used in the USA.
The FDA, through its conducted procedure, has confirmed that DRP complies with safety standards for medical devices, including those related to telemedicine-based cardiac diagnostics. FDA approval allows for the commercial deployment of this platform in the US market, which utilizes a new generation of artificial intelligence algorithms, DeepRhythmAI, also developed by the Issuer. The DeepRhythmAI DRAI algorithms enhance diagnostic accuracy and the detection rate of heart disorders. The use of DRP automates and significantly accelerates the data analysis process by an EKG technician, improving its efficiency. The DRP platform operates on cloud technology, allowing it to be used from any location and on any device including tablets.
The DeepRhythm Platform, along with DeepRhythmAI, is an innovative tool for diagnosing arrhythmias and other heart disorders. It can be used with mobile heart monitoring devices, including fourth-generation PocketECG recorders produced by the Issuer. DRP meets the requirements of standards ANSI AAMI IEC 60601-2-47:2012/_R_2016 and IEC 60601-2-25, which define specific requirements for the basic safety and essential performance of electrocardiographs. Additionally, the product meets a range of stringent cybersecurity requirements for medical devices as defined by the FDA. The usability of the DRP product has been confirmed based on user studies in the USA, in accordance with FDA requirements and IEC 62366 standards.
FDA approval and the prior achievement of CE/MDR certification for the DRP platform may accelerate the Company’s revenue growth. Some current partners, as well as potential customers, have expressed interest in commercializing DRP following approval. The new technology has the potential to optimize client operations, leading to greater scalability of their operations, increased efficiency resulting in savings, and the provision of the highest quality services through the use of the latest DeepRhythmAI algorithms for healthcare facilities and patients themselves.
Obtaining FDA approval for DRP in the US market is one of the key technological development goals outlined in the Company’s 2023-2026 strategy, published in current report No. 16/2023 on June 19, 2023. Therefore, the Issuer’s Management Board has decided to release this information as confidential within the meaning of the MAR Regulation to the public.