QT Medical Receives CE Mark for Home-Use 12-lead ECG

QT Medical, a leader in electrocardiogram (ECG) technology

Has once again reached another major milestone by receiving its CE Mark on its flagship product, PCA 500. In addition, QT Medical has also received ISO 13485:2016 certification as a manufacturer of high-quality medical devices by conforming to strict guidelines and high standard QMS practices.

The resting 12-lead ECG is the most commonly used test for the heart. QT Medical strives to make this useful tool available for patients to use at home. Focusing on innovations that advance telehealth and home care, QT Medical offers a revolutionary solution for managing heart health anytime, anywhere.

About PCA 500

PCA 500 is the only hospital-quality, medical standard 12-lead ECG that can be used by patients at home. Cleared by the FDA in 2018, PCA 500 has been used in medical clinics and clinical trials in the U.S., and has been successfully tested in major airlines. With CE Mark, PCA 500 will soon be available in the EU and many nations in the Middle East and Southeast Asia.

“This is definitely a market disruptor. There are many single-lead ECGs like the Apple Watch and AliveCor, but their clinical use is limited to heart rate and some arrhythmias. PCA 500 is the medical standard 12-lead ECG that can detect a full range of heart diseases, same as the ECG tests done by technicians in hospitals. To really democratize ECG in the midst of the COVID-19 pandemic, we are making PCA 500 accessible and affordable with a new service—Xpress ECG.”
— Dr. Ruey-Kang Chang, CEO of QT Medical

About Xpress ECG

Xpress ECG is an online order mail delivery service, where physicians place the order and QT Medical sends the ECG kit which includes everything patients need to complete the test in the comfort of their own homes. The service was launched in June 2020, and many cardiologists, electrophysiologists, and primary care physicians have registered to use it.

In the COVID-19 pandemic, patients with heart disease have a much higher risk of infection and mortality. Using Xpress ECG minimizes the potential risk of exposure in these patients. Using PCA 500 in clinics also helps to reduce the risk of disease transmission between patients from contaminated ECG leadwires and electrodes.