The US Food and Drug Administration has registered Qpatch, an ECG wearable unit developed by experts from Medicalgorithmics. The FDA approval allows use of ECG readings from Qpatch in the US
Qpatch is a state-of-the-art wearable device for measuring individual ECG signal to obtain accurate cardiac arrhythmia diagnosis across many days. It allows ECG monitoring sessions, lasting up to 15 days, for a single patient.
“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.
Our arrhythmia diagnostic technology is known as the industry’s most accurate method of diagnostic reporting and clinical data presentation. For example, our solution has been selected for a prestigious clinical trial conducted by leading research centers that are part of the Cardiac Surgery Research Network (CTSN). The project is funded by the National Heart, Lung, and Blood Institute (NHLBI) and the National Institutes of Health (NIH).
On top of the clear clinical value Qpatch also provides a number of functional advantages for the individual patient. The key features include an eInk screen that facilitates interaction with the wearable. Currently, there is no other patch ECG unit available on the market that would use a graphical user interface and a screen to interact with patients and nurses. Another important feature is the real-time ECG reading that can be observed via Near Field Communication on a smartphone. This allows ongoing quality control of the recorded ECG signal. And thanks to its waterproofness we could use standard electrodes that are inexpensive, while the low weight (25 grams / 0.88 oz) makes the device very convenient.
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,” said Mr. Jarosław Jerzakowski, Member of Board of Medicalgorithmics.
Source: Company Press Release