- G Medical Innovations (GMV) has announced its heart monitoring ECG patch has been given Emergency Use Authorisation for patients being treated for COVID-19 in the United States
- There are more than 1.5 million cases of COVID-19 in America, which the company said will present a large addressable market
- The VSMS ECG patch can identify prolonged QT intervals which indicates a rhythm disorder in the patients heart
- Following the approval from the US Food and Drug Administration, manufacturing of the patch has ramped up at G Medical’s Israeli facility
- The patch is also entitled to reimbursements under the US CPT code scheme which the company says will add to their revenue profile
- G Medical saw its share price gain 15.2 per cent at market close, with shares trading for 8.3 cents each
G Medical Innovations’ (GMV) heart monitoring ECG patch has been given Emergency Use Authorisation (EUA) for patients being treated for COVID-19 in the U.S.
The US Food and Drug Administration (FDA) said there are no adequate alternatives available in the market other than the company’s Vital Signs Monitoring System (VSMS) patch to monitor the hearts of American COVID-19 patients.
G Medical has ramped up manufacturing of the VSMS patch at its Israeli facility, with the company identifying an addressable market for the patch with more than 1.5 million COVID-19 cases in the U.S.
Company CEO, Dr Yacov Geva, said the approval from the FDA was an outstanding development for the company.
“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,” he said.
“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.”G Medical Chief Executive Officer, Dr Yacov Geva,
The patch and how it works
The VSMS patch monitors – remotely – 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 whereby an individual’s heart muscle takes longer to recharge between beats, which can potentially lead to fainting, seizures or sudden death.
QT syndrome prolongations are usually measured on a 12-lead ECG at various time points during drug exposures. However, the use of a 12-lead ECG for patients being treated for COVID-19 is burdensome and presents additional risk to patients and healthcare professionals due to the need for in-person consultations.
The company reports that the FDA has now concluded that the patch may be effective for remotely monitoring QT syndrome prolongations in COVID-19 patients and may reduce the risk of a healthcare professional’s exposure to the disease.
During the monitoring period, the patch will record and transmit ECG data, which will be saved and wirelessly transmitted to G Medical Diagnostic call centres for analysis. A certified cardiographic technician at the call centre will then compile the clinical findings and send an extensive report to the prescribing physician at the hospital.
G Medical saw its share price gain 15.2 per cent at market close, with shares trading for 8.3 cents each.