US-based Fisher Wallace Laboratories has obtained approval from Health Canada for its Fisher Wallace Stimulator, a portable brain stimulation device designed for treating insomnia and chronic pain.
The battery-powered medical device delivers a gentle electrical current to the brain to stimulate the production of serotonin, melatonin and other neurotransmitters responsible for healthy sleep and pain suppression.
Health Canada has approved the Fisher Wallace Stimulator based on the evaluation of safety and effectiveness data obtained from multiple published studies involving hundreds of patients.
According to Fisher Wallace Laboratories, the published research and clinical practice indicate that Fisher Wallace Stimulator has a 75% success rate in reducing or eliminating multiple forms of insomnia and chronic pain.
In addition, no adverse events were recorded with the device during any study and the device causes no serious side-effects.
Fisher Wallace Stimulator is safe to use with or without medication and no prescription is needed for the device in Canada, according to the company.
Fisher Wallace Laboratories president Charles Fisher said that Health Canada approval of the Fisher Wallace Stimulator medical device is a significant milestone for the company and for insomnia and chronic pain patients across Canada.
"It means that for many insomnia and chronic pain sufferers, relief is just 20-minutes away," Fisher added.
Fisher Wallace Stimulator is patented in the US and is available in the country. The device obtained approval from the US Food and Drug Administration in 1991 for the treatment of insomnia, anxiety, depression and chronic pain.