The US Food and Drug Administration (FDA) has approved Medicalgorithmics’ ECG wearable unit, Qpatch.
The new ECG wearable device has been designed to measure individual ECG signals and obtain accurate cardiac arrhythmia diagnoses from monitoring sessions of up to 15 days.
It features an eInk screen that allows physicians and patients to interact with the wearable.
Qpatch also provides real-time ECG readings that can be observed through near-field communication on a smartphone.
This allows ongoing quality control of the recorded ECG signal.
Medicalgorithmics board member Jarosław Jerzakowski said: “Securing the FDA approval for Qpatch is a major milestone celebrating the intensive effort that we have put into this project.
“Thanks to Qpatch our offer is now comprehensive. ECG diagnostics using wearables is very popular in the US and a method desired by both physicians and users.
“The FDA approval is a green light for us to prepare Qpatch’s market entry in the United States. We also want to pursue foreign markets as quickly as possible in regions where we have already been developing our sales.”
The company stated that the new device is waterproof, can be used with standard inexpensive electrodes and has a low weight for convenience.
It also noted that the Qpatch ECG monitoring device has been selected for a clinical trial that will be conducted by leading research centres in the Cardiac Surgery Research Network (CTSN).
The National Institutes of Health (NIH) and National Heart, Lung and Blood Institute (NHLBI) will provide funds for the trial.