The FDA has awarded Breakthrough Device designation to a VR mental health therapy developed by OxfordVR.

OxfordVR, a startup hailing from the UK, has pioneered techniques for harnessing virtual reality. VR Their program, Gamechange, has just earned the FDA’s Breakthrough Device status, a crucial milestone paving the way for the approval of advanced virtual reality treatments aimed at individuals grappling with a spectrum of mental health issues, ranging from anxiety disorders to serious conditions like psychosis.

Receiving Breakthrough Device status accelerates the path towards approval for this therapeutic approach. OxfordVR has successfully conducted trials in collaboration with the Wounded Warrior Project and the NHS in the UK. Additionally, recent research featured in a UK medical journal highlighted the positive impact of Gamechange on patients with severe cases of agoraphobia, a condition that induces intense anxiety when facing situations where escape may be challenging.

Deepak Gopalkrishna, the CEO and co-founder of OxfordVR, expressed his enthusiasm for the FDA's endorsement, describing it as a monumental victory for both patients and the wider mental health sector, affirming the belief that this technology has the potential to revolutionize treatment for some of society’s most intricate mental health challenges. Forbes While virtual reality has been utilized by mental health professionals to support veterans with post-traumatic stress disorder (PTSD) for several years, it remains a relatively niche aspect of the healthcare landscape. A study published in 2014 suggested that while VR could prove useful for medical training, education, and therapy, it was still at an early stage and required substantial development, including controlled studies, before becoming mainstream. The Lancet, OxfordVR's achievement in gaining serious attention from the FDA for the Gamechange initiative could signify a pivotal moment in the advancement of practical and advantageous applications of VR technology in mental health treatment.

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In a remarkable funding round, Tripp secured $11.2 million from top-tier investors to develop a mindfulness-focused virtual environment. the NIH Meta is set to release its highly anticipated Project Cambria VR headset later this year.

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