- G Medical Innovations’ (GMV) Prizma medical device has been granted approval by the Taiwan Food and Drug Administration
- Prizma is a medical smartphone case that allows users to monitor vital health signs as well as store the information
- This approval marks a major milestone for the company as it allows entrance in the Taiwan market
- G Medical’s share price has soared 42.3 per cent and is trading for 18.5 cents each
G Medical Innovations’ (GMV) Prizma medical device has been granted regulatory approval by the Taiwan Food and Drug Administration (FDA).
The mobile and e-Health company heard the news from its partner, First Channel (FCL).
“Being granted approval by the Taiwan Food and Drug Administration is a tremendous achievement for G Medical,” CEO and Executive Director Dr Yacov Geva said.
“The process has involved rigorous testing, which has outlined the safety and effectiveness of the Prizma device,” Dr Yacov added.
Prizma is a medical smartphone case and allows consumers to turn their phone into a mobile medical monitor to measure a range of vital signs. An added advantage will see users able to store their medical data in the cloud and share it with healthcare professionals and family members.
FCL has until April 4 2020 to provide the FDA with product information on Prizma. Once complete, G Medical and FCL will start negotiations for a binging agreement to detail the terms of distribution within Taiwan.
“The company will remain in discussions with FCL regarding a commercial strategy for the region, as well as assess additional opportunities where applicable,” the CEO added.
Not only is the company targeting Taiwan, but it has also recently completed trials to determine whether Prizma will be distributed in China.
As G Medical has previously advised, the distribution of its products by FCL remains subject to FCL finalising and entering into additional agreements with third party partners.
G Medical’s share price has soared 42.3 per cent and is trading for 18.5 cents each at 11:05 am AEDT.