Melbourne-based Novita Healthcare (ASX:NHL) has announced that its wholly-owned subsidiary TALI Health has been issued with an Australian Register of Therapeutic Goods (ARTG) Certificate by the TGA for the inclusion of TALI Train as a Class 1 Medical Device.
ARTG inclusion is a legal requirement to supply any medical device in Australia.
TALI Train uses software algorithms to monitor and assist in the treatment of cognitive problems such as attention difficulties in early childhood.
It is a game-based training program used to treat and monitor childhood difficulties, such as inattention. The company said the program is the first to be designed specifically for the needs of children with development disorders such as autism spectrum disorder, ADHD, Down syndrome and non-specific intellectual disability.
According to Novita Healthcare managing director Glenn Smith, “The TGA’s inclusion of TALI Health as a medical device is a regulatory milestone as it supports the broader healthcare sector adoption of TALI Train across Australia and is an important step in the global regulatory process for TALI Train."