http://www.vuvee.com/mind-machine-review-to-entrain-or-entertain/ My journey to find spirituality, health and inner peace. Tue, 20 Jul 2010 22:15:55 +0000 hourly 1 http://wordpress.org/?v=3.0 http://www.vuvee.com/mind-machine-review-to-entrain-or-entertain/comment-page-1/#comment-431 Robert Austin Mon, 15 Jun 2009 17:49:10 +0000 http://www.vuvee.com/mind-machine-reviews-to-entrain-or-entertain/#comment-431 Thanks for the great review! I just wanted to add that the FDA has made clear that US manufacturers of light and sound devices cannot make health related claims without first gaining FDA approval. We looked into this, they require studies with at least 400 participants, and the over cost for approval would be more than $1 million. David Siever lives in Canada, which has much laxer regulation, and so he can report on positive health findings. Our own machines have been used in a number of clinical studies, with positive results, but, alas, we can't share them without crossing the FDA 'line'. Regards, Robert Austin Thanks for the great review! I just wanted to add that the FDA has made clear that US manufacturers of light and sound devices cannot make health related claims without first gaining FDA approval. We looked into this, they require studies with at least 400 participants, and the over cost for approval would be more than $1 million. David Siever lives in Canada, which has much laxer regulation, and so he can report on positive health findings. Our own machines have been used in a number of clinical studies, with positive results, but, alas, we can’t share them without crossing the FDA ‘line’.
Regards,
Robert Austin

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