Medical device company G Medical Innovations (ASX: GMV) has announced it received an interim regulatory approval for its Prizma medical smartphone case and will now be admitted into the “Green Channel” of the Guangdong Provincial CFDA regulatory approval process.
The news effectively validates G Medical’s proprietary product and moves it closes to final regulatory approval in the near future. Once G Medical secures final approval from the CFDA, it will have the opportunity to commercialise the Prizma Medical Smartphone Case across China.
G Medical’s Chinese subsidiary, Guangzhou Yimei Innovative Medical S&T, is the first company to receive such approval by the Guangdong Provincial CFDA in 2018, with only 21 medical devices being approved by the agency in the entirety of 2016.
One other key benefit for G Medical is that the grant also delivers additional benefits, including expedited future CFDA applications and a reduction in local enterprise income tax from the normal 25% down to 15%.
G Medical’s Prizma case
G Medical specialises in innovative next-generation mobile and e-health solutions using a range of medical devices and software solutions with a view to driving multiple revenue streams.
The Prizma case is designed to provide novel functionality that enables users to essentially carry their own medical monitor, measuring a series of vital signs. This information can be used in multiple ways to deliver positive results for the user and G Medical as a company.
According to G Medical, all Prizma users can store their medical data in the cloud for easy access and are able to share information with third parties should this be required.
Over time, G Medical hopes to expand its range of functionality and to establish sales channels in several key regions globally, having acquired regulatory approval in the US, Europe and Japan already.
“Guangdong CFDA Green Channel approval represents a strong vote of confidence that will allow the Company to expedite its regulatory obligations moving towards the commercialisation stage. With FDA, CE and TGA approvals already granted for the Prizma Medical Smartphone Case, we are looking forward to receiving the CFDA approvals and launching Prizma in China, one of our key markets,” said G Medical CEO Dr Yacov Geva.