G Medical Innovations recently announced that it received FDA emergency use authorization for its vital signs monitoring system ECG patch for remote monitoring of patients who are being treated for COVID-19.
The patch monitors the QT interval of an ECG in patients to watch for fatal arrhythmias that may occur from treatment drugs. Prolonged QT intervals could indicate a rhythm disorder in the heart, according to the company. The condition can lead to fainting, seizures or sudden death.
“This authorization 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 recognized as being able to help ease the burden of COVID-19 on the US healthcare system,” CEO Yacov Geva said in a news release.
Under the emergency use authorization, the FDA said that “there is no adequate, approved and available alternative to the emergency use of the VSMS Patch for remote monitoring of the QT interval of an ECG in patients who are undergoing treatment in a hospital setting for COVID-19 with the drugs that can prolong QT intervals and may cause life-threatening arrhythmias.” The agency also said that the system’s remote monitoring could reduce healthcare professionals’s risk of exposure to the virus during the COVID-19 pandemic.
“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,” Geva said. “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 organizations continue to push towards telehealth and remote patient monitoring.”
G Medical Innovations said it will manufacture the patch at its wholly-owned research and development facilities in Israel and through an FDA and ISO certified medical device contract manufacturer in Israel.