Medicalgorithmics S.A., a provider of advanced cardiac solutions, has received information from the Food and Drug Administration (FDA) about approving the proprietary PocketECG CRS cardiac rehabilitation system for use and sales in the United States. The Company will soon initiate actions to commercialize the system in the U.S.On July 12, 2018, Medicalgorithmics S.A. received a notification from the Food and Drug Administration (FDA) that the Company’s proprietary system called the Unified Cardiac Rehabilitation System PocketECG CRS was cleared under the procedure 510(k). The system’s clearance means that it can be distributed in the United States. In 2016, PocketECG CRS was granted sales 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.
“I am very happy that a long and complex process of registering our system has been successfully completed. Thanks to the FDA approval we can initiate actions to commercialize PocketECG CRS in the United States. First of all, we will start pilot implementations in healthcare facilities and then recruit sales representatives dedicated to system sales in the U.S.,” said Marek Dziubiński, the President of Medicalgorithmics S.A.
“Our product for remote cardiac rehabilitation is a state-of-art and most advanced telerehabilitation system. Therefore, at the beginning we offered a few large Polish hospitals pilot implementations to let them learn more about the system and gain valuable references. Moreover, it is also an opportunity to gather opinions of patients and physical therapists that shall enable us to enhance the product and adapt it to the market expectations. It turned out that many healthcare providers want to test our product. Currently, our new telerehabilitation system is used in a few renowned hospitals in our country. Over two hundred patients supervised by several dozen physicians have benefited from remote rehabilitation using PocketECG CRS. I believe that our system will also gain acceptance from physicians and patients in the U.S.,” added Marek Dziubiński, the President of Medicalgorithmics S.A.
About PocketECG CRS
PocketECG CRS is used for remote cardiac rehabilitation of people with cardiovascular diseases. The system can be used in healthcare facilities, at a patient’s home or in any other favourable environment. 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 provides online real-time full ECG transmission during training sessions. The System also generates clear reports with patient’s training summary and ECG which support physicians in making decisions with regard to the continuation or termination of the cardiac rehabilitation process.
For healthcare providers, a significant benefit from using the Medicalgorithmics system is the reduced cost of rehabilitation. The system enables to treat more patients, since training in a facility requires less time spent by a physical therapist, and trainings at home let the patient save time. The use of the system does not require investment in additional rehabilitation equipment. Moreover, the motivation and educational modules provide a significantly higher rehabilitation efficiency.
Primary system advantages
- Comprehensive picture of the patient fitness
PocketECG is the only device on the market which provides online real-time full ECG transmission during the entire rehabilitation session. This way the physician gains a comprehensive picture of the patient fitness during exercises.
- Instant arrhythmia detection
Worldwide unique algorithms analyze each heartbeat. It enables to instantly detect any kind of arrhythmia and stop training if alarming symptoms occur.
- Patient activity monitoring
The built-in accelerator enables to track patient’s physical activity, and the system correlates it with the occurring arrhythmias and heart rate changes. Therefore, the physician can adjust training intensity to the patient’s capabilities.
- Intuitive and simple operation
Large icons and simple audible and visual commands make it easy to operate the device supervising the training even for the elderly. Moreover, patients gain comfort while working out at home or outdoors.
- Progress overview
The physician receives an individual overview of the course and progress of all patients’ trainings. A tool for scheduling sessions at a time convenient for both the facility and the patient is also available.