Regulators in Australia and New Zealand have approved G Medical's 'PRIMZA' medical smartphone case.
Australia's TGA and New Zealand's MEDSAFE approved the case that use medical sensors to transform a smartphone in a mobile medical health monitoring device.
The approvals, which follow similar positive outcomes in the US and Europe, mean PRIMZA can be made available over the counter as a medical device. The company said it is now expediting commercialisation plans in Australia.
The company also offers a professional real-time patients continuous monitoring solution - the G Medical Patch (GMP). This patch measures a wide range of vital signs that are automatically presented in a call centre (IDTF) or hospital settings. The GMP assists in diagnosing patients’ complaints and conditions remotely, from pre-hospitalisation, hospitalisation and through post discharge home-based settings.
G Medical said regulatory approvals for the patch are in the final stages in the US, Europe and China.
According to CEO, Dr Yacov Geva, “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.”