Cardiac Rehabilitation System Clearance by the U.S. Food and Drug Administration (FDA)
Current Report No 27/2018
Legal basis: Article 17(1) of MAR – inside information
The Management Board of Medicalgorithmics S.A (hereinafter “the Company”) hereby informs that on July 12, 2018 it received a notification from the U.S. Food and Drug Administration (FDA) that the Company’s proprietary system called the Unified Cardiac Rehabilitation System PocketECG CRS (hereinafter: “Pocket ECG CRS”, “System”) was cleared under the procedure 510(k). The System’s clearance signifies that it can be commercially distributed in the United States.
In 2016 PocketECG CRS was granted marketing authorization in the European Union and approved by the Office for Registration of Medicinal Products in Poland. The System is used for hybrid cardiac rehabilitation in patients with cardiovascular diseases. The main features of PocketECG CRS include: planning of rehabilitation trainings, ECG monitoring during physical activity with automatic detection of arrhythmia episodes, as well as the patient communication and training instructions module. The solution ensures online real-time full ECG transmission during training sessions. The System also generates clear reports providing the patient’s training summary and ECG, which support physicians in making decisions with regard to the continuation or termination of the cardiac rehabilitation process.
The FDA’s clearance enables the Company to begin to commercialize the PocketECG CRS in the United States by launching pilot projects in health care centers and recruiting sales representatives for the distribution of the System in the United States.