The designation was based in part on a randomized controlled trial of the device evaluating the feasibility, efficacy and acceptability of virtual reality ...
source https://www.google.com/url?rct=j&sa=t&url=https://www.painmedicinenews.com/Online-First/Article/10-20/Virtual-Reality-Device-Receives-FDA-Breakthrough-Approval-for-Fibromyalgia-Low-Back-Pain/60959&ct=ga&cd=CAIyGjg5NjVlMGM0YzM3ZjhiODc6Y29tOmVuOlVT&usg=AFQjCNEHvUV2ryusRuhE_aZgsrMfjVzJuQ
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