JVCKENWOOD Completes Clinical Trial on the Gazefinder
Eye-Tracking Assessment System for Autism Spectrum Disorder
Applied for Medical Device Approval with the Australian Therapeutic Goods Administration
Yokohama, October 11, 2021—JVCKENWOOD Corporation (JVCKENWOOD) has completed a clinical trial in Australia on the assessment of Autism Spectrum Disorder (ASD) using the Gazefinder eye-tracking system, which was conducted in collaboration with La Trobe University*1 and Telethon Kids Institute*2 in Australia. JVCKENWOOD submitted an application to the Australian Therapeutic Goods Administration (TGA) for medical device approval of an ASD assessment tool based on the Gazefinder eye-tracking technology.
The trial started in January 2020 at two sites, La Trobe University and Telethon Kids Institute in Australia. Gazefinder, with JVCKENWOOD's ASD assessment program, was used to assess children with a diagnosis of ASD and Typically Developing (TD) children, aged two to four years. Efficacy and safety were verified by comparing the Gazefinder assessment results with those of conventional diagnosis by community professionals, and results from behavioural ASD assessment completed by the research teams. Since sufficient results were obtained for over 200 children, this clinical trial was completed. In response to the results, JVCKENWOOD submitted an application for medical device approval to the Australian TGA for an ASD assessment tool that applies technology of the Gazefinder eye-tracking system.
Assessment using the eye-tracking system
The ASD assessment tool uses JVCKENWOOD's unique eye-tracking technology to measure and visualize the line of sight by simply having the child look at the image on the monitor. It enables eye tracking children with ASD as young as 2-years of age, who are often difficult to assess. The assessment tool has a number of advantages, including the fact that it takes only about two minutes to complete and the operator does not need any special technical skills. The use of this assessment tool will enable professionals to increase the objectivity of their assessment results, and is also expected to speed up the ASD diagnostic process compared to the assessment time that takes at least one hour with conventional assessment tools.
Australian research teams – including at La Trobe University and the Telethon Kids Institute – have internationally-recognized expertise for work on the early identification, diagnosis and intervention with very young children with autism, from birth to school entry. By increasing opportunities for ASD assessment from early childhood, JVCKENWOOD will promote access to effective treatment and education in early life and contribute to improving quality of life of children and families in a diverse society.
This document is based on the information available at the time of release and may differ from the latest information.
*1： University based in Melbourne, Victoria, Australia
*2：Medical research institute based in Perth, Western Australia, Australia