FDA Grants Breakthrough Device Designation To VR Mental Illness Treatment

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Deepak Gopalkrishna, OxfordVR CEO says its virtual reality treatment have already been trialled with the U.K.’s NHS and the Wounded Warrior Project.A British startup that uses virtual reality to help deliver cognitive behavior therapy has been granted a Breakthrough Device designation by the Food and Drug Administration for its treatment for schizophrenia and other serious mental illnesses, a process that will help expedite its ultimate approval if clinical trials pan out.

The FDA’s grant of breakthrough device status will fast-track the testing and approval of the startup’s VR treatment, for which has already run trials with U.S.-based veterans charity Wounded Warrior Project and the U.K.’s National Health Service. A clinical review of OxfordVR’s Gamechange treatment published in April by the medical journal"Serious mental illness is an enormous issue that cannot be solved with existing approaches alone.

 

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