Class II Medical Device For Specific Phobias (Agoraphobia) Approved

The Hubei Provincial Drug Administration intervened in advance and linked up the research and examination. We helped enterprises to solve their testing and declaration problems.

The enterprises communicated with the reviewers several times before the products were sent for inspection and declaration. The reviewers helped and guided the enterprises on issues such as product classification, declaration form and clinical evaluation. A team review model (one lead reviewer and two reviewers) was adopted to improve the efficiency and quality of the review process.

Members of the team communicated and discussed the research data and clinical issues of the product for many times, and invited a number of authoritative experts in psychiatry in the province to provide clinical control and guidance. The technical review was completed in just 20 working days.

　　The approved specific fear psychological rehabilitation software is a VR exposure therapy aid for agoraphobia built in collaboration with Shanghai Mental Health Centre.

The product creates an exposure scenario for people who are afraid of heights to wear VR equipment, so that psychiatrists can choose the appropriate exposure intensity and tasks according to the actual situation of the patient in the process of exposure therapy, helping patients to identify and correct irrational fears, counteract avoidance reactions and conduct corresponding relaxation training, ultimately achieving the treatment effect of reducing symptoms of fear of heights and improving the quality of life. The result is a reduction in agoraphobia and an improvement in quality of life.

　　The product needs to be used under the supervision of a professional psychotherapist in a professional psychiatric or medical setting. Clinical results have shown that patients with agoraphobia treated with VR exposure have nearly a 50% reduction in height anxiety and avoidance behaviour (as measured by the Agoraphobia Questionnaire AQ), as well as a significant improvement in their perception of height (as measured by the Height Inventory HIQ) and clinical manifestations of anxiety (as measured by the Beck Anxiety Inventory BAI).

In addition, with the exception of mild vertigo (as measured by the Simulator Vertigo Scale SSQ) caused by the VR device, no subjects reported an inability to adapt or the need to discontinue the trial during treatment, nor did any subjects actively report or mention any adverse effects during the follow-up period after study completion.