Mobile and e-Health company G Medical Innovations Holdings (ASX: GMV) has been granted over-the-counter authorisation for its Prizma medical smartphone case by the US Food and Drug Administration.
The authorisation allows the device to be sold in the US as an over the counter item without the need for a prescription and was based on the nation’s COVID-19 public health emergency policy.
Prizma allows consumers to turn their smartphone into a mobile medical monitor to measure a range of vital signs including temperature, heart rate, stress levels and blood oxygen saturation which can be used to detect symptoms associated with infection and chronic illness.
Users can store their medical data in the cloud and share it with third parties such as healthcare providers and family members.
It is believed to be the only solution on the current market to offer comprehensive health profiling and monitoring for medical professionals and individual patients.
The USFDA acknowledged that Prizma falls within the policy scope for “non-invasive remote monitoring devices that measure or detect common physiological parameters and are used to support patient monitoring during the COVID-19 public health emergency”.
Reducing healthcare burden
G Medical chief executive officer Dr Yacov Geva said securing over-the-counter authorisation was a significant achievement for the company.
“This is a monumental development which provides us with direct access to consumers, physicians and healthcare providers who are currently in need of our solutions,” he said.
“We are confident the product will be well received and can hopefully assist in reducing the burden on the [US] healthcare system, which is undergoing capacity challenges directly related to the COVID-19 public health emergency.”
He said G Medical is currently working on strategies to penetrate the US consumer market and capitalise on the “significantly large opportunity”.
Commercial negotiations to expedite market entry are underway.
The company will also update Prizma’s packaging to reflect the USFDA’s authorisation.