The US Food and Drug Administration (FDA) has granted approval for Caputron Medical's mindGear headset for the treatment of serious psychiatric diseases such as depression, insomnia and anxiety.
After more than five years of therapy optimisation and clinical testing, mindGear was approved to provide patients immediate and lasting relief through a drug-free therapy.
For many patients with psychiatric diseases, drug-based treatments do not provide sufficient relief and cause severe side effects.
Caputron's mindGear is a small battery powered device that connects to the head via special hydroPod electrodes. It is a neuromodulation therapy that gently activates the brain in a way that encourages endogenous healing.
Caputron Medical US sales vice-president Jennifer Higgins said: "mindGear represents a major advance in the wearable tech and digital health space.
"Portable, personal, and customisable, mindGear is both a consumer and medical neuromodulation device."
The device secured FDA clearance for indications, including depression, insomnia and anxiety with further clinical trials for new indications ongoing.
mindGear, which can be used in almost any environment, is available in the US with a prescription.
Caputron Medical CEO Robin Azzam said: "Neuromodulation, also called electroceuticals, is the fastest growing area in the treatment of neurological and psychiatric disorders.
"mindGear further establishes Caputron Medical as a leader in the personalised therapy space with a handheld and personalised device."
The company is a distributor of consumer, clinical and research neurostimulation technology and is aimed at improving the field through the development and distribution of new therapeutics and through the support of research devices.
Image: mindGear is a gentle, drug-free treatment cleared by the FDA for depression, anxiety and insomnia. Photo: courtesy of Caputron Medical.