This is NeuroTx's first CES Innovation Award, securing its position in the digital health field. This device is being promoted for approval as a digital therapeutic in Korea, and has a high possibility of entering the global insomnia market upon approval from the FDA, etc. in the future.
Technically, sleep stages can be detected more precisely by adding a brainwave sensor, or it can be applied to other brain diseases such as depression and anxiety disorders. Vagus nerve stimulation is also used to treat depression, so it seems possible to expand to overall mental health with one platform device. As user data accumulates, the accuracy of AI coaching also increases, so there is room for development into a service-type platform.
In terms of regulations, medical device approval must be obtained in each country, but clinical data is already solid and there is a high unmet need for insomnia, so regulatory agencies are expected to be favorable.