G Medical Received FDA Clearance for Prizma OTC Authorisation in the US
Mobile and e-Health Company G Medical Innovations Holdings Limited (ASX:GMV) is aiming to be at the forefront of the digital health revolution, developing the next generation of mobile health (mHealth) technologies. The Company focuses on pioneering next-generation mobile and e-health solutions using its suite of proprietary devices and software solutions.
GMV revealed that, for its Prizma device, it had received Over-the-counter (OTC) authorisation by the US Food & Drug Administration (FDA).
In consideration of the FDA COVID-19 Policy, the Company directly contacted the FDA seeking acknowledgement that the Prizma medical device satisfied the Policy scope for authorization, defined as “noninvasive remote monitoring devices that measure or detect common physiological parameters and that are used to support patient monitoring during the COVID-19 public health emergency.”
Moreover, the Company believes the Prizma device can assist in alleviating pressure on the US healthcare systems, which are undergoing capacity challenges directly related to the COVID-19 public health emergency.
In an ASX update dated 14 April 2020, the Company provided a corporate and business update. It highlighted that the recent regulatory approvals in the US, Taiwan and Italy leave the Company well-positioned for further growth and developments. It is noteworthy that in Italy, GMV has started the fulfilment of Prizma units to its partner.
GMV Price at posting:
9.6¢ Sentiment: Buy Disclosure: Held
