Mobile and e-Health company G Medical Innovations Holdings Ltd (ASX: GMV) has been granted Therapeutics Goods Administration (TGA) approval and certification by the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for its PRIZMA Medical Smartphone Case.
G Medical CEO Dr Yacov Geva, said this is another significant milestone for the company, whereby the PRIZMA now officially complies with all relevant Australian and New Zealand medical and safety requirements as a Class IIa Medical device.
According to Dr Geva, these certifications effectively mean that the PRIZMA can be made available over the counter as a medical device throughout Australia, New Zealand and additional countries accepting TGA and MEDSAFE certifications.
“Being granted TGA and MEDSAFE certification allows, in particularly for our Australian shareholders, to fully appreciate the tremendous opportunity at hand for our company, in providing necessary and unmet medically graded solutions for the monitoring, management and collection of an enormous pool of data for chronic illnesses; as well as providing disruptive and highly cost effective and scalable solutions for the greater healthcare and hospital ecosystems worldwide,” Dr Geva said.
These additional certifications add to the previously granted approvals for the PRIZMA by U.S Food and Drug Administration (FDA) 510(K), as well as the European ‘CE’ Class IIa approval, effectively opening up the Global Market for the PRIZMA.
Dr Geva said that with these additional certifications in place, the company can now expedite the ongoing commercial discussions with its potential partners on new agreements.
G Medical Innovations offers a suite of consumer and professional clinical-grade products (regulatory approved) that are positioned to streamline healthcare services, improve remote access to medical data, reduce costs, improve quality of care, and make healthcare more personalised and precise.
The PRIZMA Medical Smartphone Case is one of the innovative products on offer from G Medical, which combines everyday technologies with patented wireless medical sensors and service platforms, practically turning consumers smartphones into a mobile medical health monitoring solution.
