- Meditech innovator G Medical (GMV) has been granted special FDA approval for non-prescription, over-the-counter use of its Prizma device in the U.S.
- The Prizma device is a real-time mobile monitoring system, which allows consumers to use their smartphone to check vital signs
- The device was granted the approval amid the current need for remote monitoring systems to ease the burden on healthcare providers
- The fact the Prizma device can now be obtained without a prescription is a boon for G Medical as it seeks to expand its US footprint
- G Medical is up a remarkable 144.4 per cent today, with. shares trading at 11 cents each
Meditech innovator G Medical (GMV) has been granted special FDA approval for non-prescription, over-the-counter use of its Prizma device in the US.
What is Prizma?The Prizma device is a real-time mobile monitoring system, which allows consumers to use their smartphone to check vital signs including temperature, heart rate, stress levels, SPO2 (blood oxygen saturation) and electrocardiography (ECG).
Each of these data points are physiological biometrics that can be measured to detect symptoms associated with infection and chronic illness. The advantage is that users are able to store their medical data in the cloud and share it with third parties, such as healthcare professionals and family members.
Prizma's usefulness in the current climate is two-fold. Firstly, it can help monitor patients with pre-existing, underlying conditions which require vital signs monitoring. Prizma can deliver this information remotely 24/7, alleviating the need for in-person checkups and the resulting burden on the healthcare system.
Secondly, given the current COVID-19 crisis, Prizma can be deployed to monitor people who are suffering symptoms of the virus, keeping a watchful eye over potentially worsening conditions. The combination of mobile, constant monitoring and the lightening of the burden on the healthcare system are what qualified Prizma for expedited approval for over-the-counter use.
Market OpportunitiesOne important thing about the FDA approval is that even though it has been granted under a new special framework to deal with COVID-19, the approval is still permanent rather than temporary. Given the device's capacity to provide a direct data feed to healthcare providers, or to trigger alarms for the patient if certain metrics reach warning levels, there are wide-ranging applications for the device into the future.
The fact the Prizma device can now be obtained without a prescription is a boon for G Medical as it seeks to expand its US footprint. The company says it is in ongoing discussions with a number of potential partners to expedite a broader consumer-focused launch.
G Medical CEO and Executive Director Dr Yacov Geva says getting the green light from the FDA opens a lot of doors for Prizma in the lucrative US market.
"FDA over-the-counter authorisation is a monumental development for G Medical and provides us with direct access to consumers, physicians and healthcare providers who are currently in need of our solutions," Dr Yacov explained.
"We are confident that the product will be well received and can hopefully assist in reducing the burden on the healthcare system, which is currently inundated."
CEO and Executive Director Dr Yacov Geva
"G Medical is currently delineating a number of ways to penetrate the US consumer market and looks forward to updating shareholders on progress in the near term," he concluded.
G Medical is up a remarkable 144.4 per cent today, with. shares trading at 11 cents each as at 12:25 pm AEST.
https://themarketherald.com.au/g-me...ted-u-s-over-the-counter-approval-2020-04-08/
