REHOVOT, Israel, May 19, 2020 /PRNewswire/ -- Medical device and telehealth company G Medical Innovations Holdings Ltd (ASX: GMV) ("G Medical" or "Company") is pleased to report a significant development for the Company with receipt of Emergency Use Authorisation ("EUA") status from the US Food and Drug Administration ("FDA") for the Company's Vital Signs Monitoring System ("VSMS") ECG Patch ("Patch") for the remote monitoring of the QT interval of an ECG in patients who are undergoing treatment in a hospital setting for COVID-19 with drugs that can prolong QT intervals and may cause fatal arrhythmias.
Prolonged QT intervals outline a rhythm disorder in the heart (medically known as an arrhythmia) whereby an individual's heart muscle takes longer to recharge between beats. This can potentially lead to fainting, seizures or sudden death.
Under the EUA 'Issuance of Authorisation', the FDA concluded 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 drugs that can prolong QT intervals and may cause life-threatening arrhythmias. In addition, remote monitoring may reduce the [Health Care Professionals] HCP risk of exposure to SARS-CoV-2 during the COVID-19 pandemic."[ii]
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The Company will continue its manufacturing of the Patch at its wholly owned R&D facilities in Israel and also via an FDA and ISO certified medical device contract manufacturer in Israel, ahead of future production at G Medical's Guangzhou China production facility.
The Authorisation will be effective until the declaration that circumstances exist justifying the authorisation is terminated under section 564(b)(2) of the relevant Act or the EUA is revoked under section 564(g) of the Act.
CEO Dr 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."