Medicalgorithmics announced today that the FDA approved its Qpatch wearable device for electrocardiogram (ECG) readings.
Warsaw, Poland-based Medicalgorithmics designed the state-of-the-art, wearable device to measure individual ECG signals and obtain accurate cardiac arrhythmia diagnoses across up to 15 days of monitoring sessions.
According to a news release, Medicalgorithmics’ Qpatch has been selected for a clinical trial to be conducted by leading research centers as part of the Cardiac Surgery Research Network (CTSN), with funding provided by the National Heart, Lung and Blood Institute (NHLBI) and the National Institutes of Health (NIH).
Qpatch features an eInk screen to facilitate interaction with the wearable for the patients and physicians. The real-time ECG reading provided by the device can be observed via near-field communication on a smartphone to allow for ongoing quality control of the recorded ECG signal.
The device is also waterproof, allowing for the use of standard electrodes that are inexpensive, and has a low weight for convenience.
“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 U.S. and a method desired by both physicians and users,” Medicalgorithmics board member Jaroslaw Jerzakowski said in the release. “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.”