FDA grants Prizma Over-the-Counter (OTC) Authorisation in USA

https://gmedinnovations.com/asx-announcements/

Boom Boom Boom

Excerpt:

The Company is very pleased to confirm to its shareholders that the FDA confirmed that the Company’s
“proposed change to expand the use of the Prizma device from RX (Prescription) to OTC meets the criteria of
the Remote Monitoring guidance document (Policy)” [FDA]; and that the clearance is not temporary, despite
the authorisation being issued with specific application to, and in consideration of the COVID-19 Policy.


CEO and Executive Director Dr Yacov Geva said: “FDA OTC authorisation is a monumental development for G
Medical and provides us with direct access to consumers, physicians and healthcare providers who are
currently in need of our solutions. We are confident that the product will be well received and can hopefully
assist in reducing the burden on the healthcare system, which is currently inundated.
“G Medical is currently delineating a number of ways to penetrate the US consumer market and looks forward
to updating shareholders on progress in the near term.”