FDA grants Prizma over-the-counter authorisation, G Medical shares surge 200%

As the world battles the coronavirus pandemic, G Medical (ASX: GMV) has secured authorisation from the Food and Drug Administration to sell their Prizma smartphone attachment direct to customers without the need for a prescription, rocketing the company’s share price. 

Prizma, a smartphone attachment which can monitor a user’s vital signs, can play a vital role in alleviating pressure off healthcare workers as identified last month on The Sentiment when G Medical was trading at 4.2c per share. 

The sudden FDA authorisation comes amidst the FDA’s response to the COVID-19 health emergency and new guidance policy. 

Accordingly, Prizma’s medically certified technology has been acknowledged and qualified specifically that “in respect of the COVID-19 public health emergency, the leveraging of current noninvasive patient monitoring technology will help eliminate unnecessary patient contact and ease the burden on hospitals, other health care facilities, and health care professionals that are experiencing increased demand due to the COVID-19 pandemic as it relates to diagnosis and treatment of patients with COVID-19 and ensuring other patients who require monitoring for conditions unrelated to COVID-19 can be monitored outside of health care facilities.” 

With the FDA’s acknowledgement of Prizma’s accurate and practical function to monitor heart rate, ECG, body temperature and stress levels, the smartphone attachment has been cleared for sale, direct to end-users in the United States as an over-the-counter (OTC) product.

“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,” said G Medical CEO, Dr Yacov Geva. 

“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.” 

Although elevated temperature a key symptom of COVID-19, G Medical forewarns that Prizma will be packaged to communicate that it is no substitute for professional medical advice, or a diagnostic tool for COVID-19. 

Following news of the FDA over-the-counter authorisation, shares in G Medical rose to an intraday high of $0.135, a rise of 200% on the previous close of $0.045. 

G Medical did not disclose any pricing information for Prizma and it’s U.S rollout.