G Medical China granted 'green channel'

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Mobile and e-Health company G Medical Innovations (ASX:GMV) has announced its China-based subsidiary has been granted acceptance to the Green Channel expedited Guangdong Provincial CFDA (China Food and Drug Administration) regulatory approval process for Prizma medical smartphone case.

The subsidiary, Guangzhou Yimei Innovative Medical S&T, is the first company to receive such approval by the Guangdong Provincial CFDA in 2018 (only 21 medical devices were approved by them in 2016).

The company says the approval will allow it to move forward towards final regulatory CFDA approval and commercialisation of the Prizma Medical Smartphone Case in China.

The Prizma is one of two key products developed by G Medical. It is aimed at everyday consumers focused on their health and wellbeing. It allows consumers to turn their smartphone into a mobile medical monitor to measure a wide range of vital signs. In addition, users can store their medical data in the cloud and share it with any third-party including professionals and family.

According to G Medical CEO, Dr Yacov Geva, “Guangdong CFDA Green Channel approval represents a strong vote of confidence that will allow the Company to expedite its regulatory obligations moving towards 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.”