G MEDICAL GRANTED EUROPEAN ‘CE’ CERTIFICATION FOR
‘PRIZMA’ MEDICAL SMARTPHONE CASE
• New ‘CE’ certification opens doors for launch and commercialisation
Mobile and e-Health company G Medical Innovations Holdings Ltd (ASX: GMV) is pleased to announce it has been granted ’European CE‘ certification for its ‘Prizma’ Medical Smartphone Case. In another significant development for the company, such that the product now officially complies with all relevant European medical and safety requirements, this effectively means that the ‘Prizma’ can be made available over the counter as a medical device in Europe and additional countries accepting CE.
The ‘Prizma’ Medical Smartphone Case is one of two key products developed by G Medical and is aimed at everyday consumers focused on their medical health and wellbeing. The ‘Prizma’ allows consumers to turn their smartphone into a mobile medical monitor to measure a wide range of vital signs, with the added advantage that users are able to store their medical data in the cloud and share it with third parties such as healthcare professionals and family members.
The company offers total solutions that include medical devices, Apps and services. These full solutions will shortly be available to consumers through various sales and distribution channels from direct B2C channels to distributors, carriers and other partners.
This certification means that the Company has now cleared another important regulatory barrier for the Prizma, and follows on from the recent announcement by G Medical that it had received U.S Food and Drug Administration (FDA) 510(K), Class II approval. ‘CE’ certification also means that G Medical has furthered its potential reach into markets that use this certification, as well as allowing for the fast-tracking of the approval process in territories that recognise CE as a precursor. With CE granted, the company can now proceed directly with potential partners on new agreements.
With similar regulatory approvals being sought in China, Australia and other markets in line with the Company’s business strategy, G Medical is excited with the progress that has been made to date and looks forward to providing business development and regulatory approval updates to shareholders as they unfold.
Commenting on the ’CE‘ certification, G Medical CEO Dr. Yacov Geva, said: “Being granted ‘CE’ certification so soon after the recent FDA announcement marks another significant development in our growth, and paves the way for the company in its business development and commercialisation efforts.”
