JelikaLite has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Cognilum System.
The new wearable, non-invasive therapeutic medical device is designed to reduce moderate to severe autism spectrum disorder symptoms in paediatric patients aged two to six years.
It is a data-device integrated system that provides neurostimulation treatment in combination with an artificial intelligence (AI) personalisation platform.
The system is intended to reduce anxiety as well as improve speech and responsiveness in children with autism.
Data from a pilot study suggests that the wearable device can significantly improve symptoms.
If approved, the device will provide families with a home-based, cost-effective and easy-to-use treatment for children with this disorder.
The FDA granted breakthrough device designation based on the data obtained from a placebo-controlled, double-blind clinical study, which was conducted in 30 paediatric patients with moderate to severe autism.
The device showed improved autism symptoms through communication and daily living skills, by combining non-invasive brain stimulation with near-infrared light, the AI platform and electroencephalography (EEG) sensors.
JelikaLite chief science officer Dr Eugenia Steingold said: “We are thrilled that the FDA recognises that we are developing a novel technology with a potential to change the landscape in the current approach to autism.
“For some of the participants in our active condition, the positive change was so dramatic that their parents expressed their desire to continue the treatment even after the study was over.
“We recognise that autism is a spectrum, and no two children are alike; our ultimate goal is to develop a personalised approach to every child based on their unique needs and challenges.”
Last month, InterVene received breakthrough device designation from the FDA for its BlueLeaf Endovenous Valve Formation (EVF) System, which is developed to address deep vein reflux.