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Medibio (ASX:MEB; OTCQB:MDBIF), a mental health technology company provides the following quarterly update. As quoted in the press release: The FDA review process continues to move forward as anticipated. Our De Novo application is in the FDA review process and our team is working with the FDA on review of our application for approval. We …
Medibio (ASX:MEB; OTCQB:MDBIF), a mental health technology company provides the following quarterly update.
As quoted in the press release:
The FDA review process continues to move forward as anticipated. Our De Novo application is in the FDA review process and our team is working with the FDA on review of our application for approval. We continue to anticipate an approval in the first calendar quarter of 2019.
Our technology offers a novel approach to psychophysiological markers of mental health and physical wellbeing, specifically designed for psychiatrists, psychologists, and general practitioners that are seeking objective measures to help diagnose and monitor depression. We are seeking to change the way mental health is viewed, by providing an objective, non-invasive, convenient means to diagnose and monitor mental illness.
Having already achieved the CE Mark from Europe and TGA clearance from the Therapeutic Goods Association in Australia, we anticipate a successful FDA approval in the U.S.