The VSMS ECG Patch has been designed to facilitate remote monitoring of the QT interval of an ECG in patients under treatment for Covid-19
G Medical Innovations Holdings, a medical device and telehealth firm, has received the Emergency Use Authorisation (EUA) status from the US Food and Drug Administration (FDA) for its Vital Signs Monitoring System (VSMS) ECG Patch.
The VSMS ECG Patch has been designed to facilitate remote monitoring of the QT interval of an ECG in patients, undergoing treated for Covid-19 with drugs that can prolong QT intervals and may cause fatal arrhythmias.
Prolonged QT intervals indicate a rhythm disorder in the heart, which is medically known as arrhythmia, where the heart muscle of an individual takes longer to recharge between beats, and may lead to fainting, seizures or sudden death.
VSMS ECG Patch will remotely monitor the QT interval of an ECG in Covid-19 patients
Through the issuance of EUA, the US regulatory agency concluded that no adequate alternative to the emergency use of the VSMS ECG Patch is available for remote monitoring of the QT interval of an ECG in patients who are undergoing treatment in a hospital setting for Covid-19.
In addition, the remote monitoring would reduce the risk of exposure to SARS-CoV-2 for health care professionals during the Covid-19 pandemic.
G Medical intends to manufacture its VSMS ECG Patch at its own facilities in Israel and also through an FDA and ISO certified medical device contract manufacturer in Israel, prior to the future production at its Guangzhou China production facility.
G Medical Innovations CEO Yacov Geva said: “This authorisation from the FDA is an outstanding development for G Medical and its value cannot be underestimated. It is heartening to see that our technology has been recognised as being able to help ease the burden of COVID-19 on the US healthcare system.
“G Medical is confident that the Patch can fill the shortage of ECG monitors that hospitals across the USA are facing and also reduce healthcare workers’ exposure to the disease.
“Our products are effective and especially relevant during the current COVID-19 pandemic and we believe that they will remain so well beyond COVID-19 as hospitals and other medical facilities and organisations continue to push towards telehealth and remote patient monitoring.”