Information on Medicalgorithmics S.A.'s FDAApproval for Use of the DeepRhythm Platform in the US Market

Current Report No: 15/2024_#160;

Date: June 24, 2024_#160;

Legal Basis: Article 17, Section 1 of the MARRegulation - Confidential Information

The Management Board of Medicalgorithmics S.A., basedin Warsaw, Poland (_quot;Company_quot;; _quot;Issuer_quot;), informs that the US Food andDrug Administration (FDA) has granted approval for the Company's newdiagnostic platform: DeepRhythm Platform (DRP) to be used in the USA.

The FDA, through its conducted procedure, hasconfirmed that DRP complies with safety standards for medical devices,including those related to telemedicine-based cardiac diagnostics. FDAapproval allows for the commercial deployment of this platform in the USmarket, which utilizes a new generation of artificial intelligencealgorithms, DeepRhythmAI, also developed by the Issuer. The DeepRhythmAI(DRAI) algorithms enhance diagnostic accuracy and the detection rate ofheart disorders. The use of DRP automates and significantly acceleratesthe data analysis process by an EKG technician, improving itsefficiency. The DRP platform operates on cloud technology, allowing itto be used from any location and on any device (including tablets).

The DeepRhythm Platform, along with DeepRhythmAI, isan innovative tool for diagnosing arrhythmias and other heart disorders.It can be used with mobile heart monitoring devices, includingfourth-generation PocketECG recorders produced by the Issuer. DRP meetsthe requirements of standards ANSI AAMI IEC 60601-2-47:2012/(R)2016 andIEC 60601-2-25, which define specific requirements for the basic safetyand essential performance of electrocardiographs. Additionally, theproduct meets a range of stringent cybersecurity requirements formedical devices as defined by the FDA. The usability of the DRP producthas been confirmed based on user studies in the USA, in accordance withFDA requirements and IEC 62366 standards.

FDA approval and the prior achievement of CE/MDRcertification for the DRP platform may accelerate the Company's revenuegrowth. Some current partners, as well as potential customers, haveexpressed interest in commercializing DRP following approval. The newtechnology has the potential to optimize client operations, leading togreater scalability of their operations, increased efficiency resultingin savings, and the provision of the highest quality services throughthe use of the latest DeepRhythmAI algorithms for healthcare facilitiesand patients themselves.

Obtaining FDA approval for DRP in the US market isone of the key technological development goals outlined in the Company's2023-2026 strategy, published in current report No. 16/2023 on June 19,2023. Therefore, the Issuer's Management Board has decided to releasethis information as confidential within the meaning of the MARRegulation to the public.