Clinical trials completed to progress China NMPA approval process:
G Medical successfully completed the required clinical trials to obtain National Medical Products Administration
(NMPA) (formerly China Food and Drug Administration or CFDA) approval for the use of its Prizma device in the
People’s Republic of China.
GMV has completed the additional trials with 208 patients across three partner hospitals. Trials included
measurements for electrocardiography (ECG), blood-oxygen saturation (SPO2) and body temperature using the
Prizma device benchmarked against the relevant ‘gold standard’ hospital diagnostic equipment. The Company continues to interpret the vast amount of statistical data generated from the exercise. Once
finalised GMV will lodge a dossier of results with the NMPA in a push to gain NMPA approval for the device.
So was not going to be end of April, if this was released 30th.
GMV Price at posting:
4.4¢ Sentiment: Hold Disclosure: Held