- Mobile health company G Medical (GMV) has updated the market on recently completed activities
- In early April, the company received over-the-counter approval from the U.S. Food and Drug Administration to begin selling its Prizma device
- Prizma is a medical mobile phone case that is designed to measure key health metrics while the user is on the move
- On April 6, G Medical received regulatory approvals for Prizma in both the Italian and Taiwanese markets
- Finally, the company is reconsidering its listing on the NASDAQ to provide more value for shareholders
- G Medical is up a steady 14.3 per cent today and shares are trading for 12 cents each
Mobile health company, G Medical (GMV) has updated the market on recently completed activities.
FDA over-the-counter approval for Prizma
In early April, G Medical received over-the-counter approval from the United States Food and Drug Administration (FDA) for its Prizma device.
The Prizma device is a phone case which is designed to measure key health metrics, such as heart rate and stress levels, while the user is on the move.
When the device is linked to the app it can inform healthcare professionals about symptoms associated with chronic diseases and illnesses.
G Medical believes that its Prizma device can help ease the pressure that is currently on the U.S. health system following the outbreak of COVID-19 as patients can monitor their own vital signs and not clog-up hospitals needed for COVID-19 patients.
Entry into Italy
On April 6, Prizma was registered on the Italian Health Ministry’s Database of Health products.
This means G Medical’s device can now be distributed in Italy and it comes at an important time as Italian hospitals are overrun with COVID-19 patients.
G Medical will work with Meditel, its distribution partner, to provide access to service solutions and telehealth technologies across Italy.
According to the company, Meditel has already ordered its first units.
Taiwanese FDA approval
Also on April 6, G Medical received a permit licence for Prizma in Taiwan which was granted by the Taiwan Food and Drug Administration.
“The Prizma device can be used to monitor systems associated with infection, chronic disease and acute illness and has been recognised by some of the world’s leading authorities, including the U.S. Food and Drug Administration,” CEO and Executive Director Dr Yacov Geva commented.
“These recent approvals, coupled with our devices capabilities and a global push towards telehealth solutions, leaves G Medical incredibly well placed to unlock value for shareholders,” he added.
G Medical has also announced that it is reconsidering listing on the NASDAQ to provide additional value for shareholders.
The company has already begun first discussions with multiple third parties and will provide updates to shareholders if anything significant arises.
G Medical initially withdrew its NASDAQ registration in August 2019 so it could focus on over-the-counter approvals.
Now that this has been granted, the company can restart this process.
“G Medical has achieved a number of pivotal milestones in the recent months, leaving it well-placed for growth and optimistic for the remainder of 2020,” Dr Yacov stated.
“The company is progressing initiatives on a number of fronts in Italy, the USA and Taiwan and we look forward to updating shareholders on its progress in the near term,” he concluded.
G Medical is up a steady 14.3 per cent and shares are trading for 12 cents each at 10:34 am AEST.