Medical device and telehealth company G Medical Innovation Holdings (ASX: GMV) has announced approval by the US Food and Drug Administration for its heart-monitoring patch to be used in emergency cases for patients undergoing treatment for COVID-19.
The company emerged from a trading halt this morning to report its Vital Signs Monitoring System (VSMS) electrocardiogram (ECG) patch had received ‘emergency use authorisation’ to remotely monitor the QT interval of an ECG in patients undergoing COVID-19 treatment in a hospital with drugs that may prolong these intervals and potentially cause fatal arrhythmias.
The QT interval on an ECG shows the time it takes for the ventricles of the heart to contract and relax. A prolonged QT interval means an individual’s heart muscle takes longer to recharge between beats. This can be a serious finding as it indicates a rhythm disorder (arrhythmia) that could potentially lead to fainting, seizures or sudden death.
According to G Medical, the FDA concluded there was “no adequate, approved and available alternative” to the emergency use of the VSMS patch in this scenario, given the shortage of ECG monitors in hospitals across the US.
The FDA also said remote monitoring may reduce the healthcare professional’s risk of exposure to the virus strain causing COVID-19 during the pandemic.
G Medical chief executive officer Dr Yacov Geva desribed the authorisation as an “outstanding development” and said “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,” 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,” Dr Geva added.
G Medical’s VSMS patch is described as an “easy-to-use, clinical grade solution used for monitoring patients through the healthcare lifecycle”.
Adult patients receiving treatment for COVID-19 with drugs that can prolong QT intervals wear the patch for up to 14 days.
During the monitoring period, the patch records and transmits ECG data, which is saved and wirelessly transmitted to G Medical diagnostic call centres for analysis. A call centre certified cardiographic technician will then compile the clinical findings and send an extensive report to the prescribing physician at the hospital.
G Medical currently manufactures the patch at its wholly-owned research and development facilities in Israel and also via an FDA and ISO-certified medical device contract manufacturer in the Middle Eastern country.
The company is planning for future production of the patch at a facility in Guangzhou, China.
In today’s announcement, G Medical said it is now “aggressively” scaling production of the patch at the Israeli facilities in anticipation of immediate demand that is likely to come from US hospitals and healthcare facilities imminently.
There are currently more than 1.5 million confirmed cases of COVID-19 in the US with numbers still expected to rise in the coming months.
The FDA’s authorisation will remain in effect until the declaration that circumstances exist justifying the authorisation’s termination, G Medical stated.