Mental health is increasing in importance worldwide and companies are trying to find unique ways to provide relief to those who struggle. And companies like Neurovalens have turned to wearables.

This month, Neurovalens’ Modius Stress wearable announced that it cleared the United States Food & Drug Administration’s (USFDA) FDA 510(k) for use in US. It’s the second product to get clearance by the USFDA. This is a huge win for the Belfast-based company that integrates neuroscience and technology to address numerous health challenges. 

The Modius Stress device essentially sends a safe electrical pulse for non-invasive stimulation to the brain and nervous system. With this new clearance, Neurovalens can begin selling the Modius Stress device directly to those who are suffering with Generalized Anxiety Disorder (GAD) in the US and have a prescription for it.

Mental health challenges like stress and anxiety can manifest in various ways, impacting everything from daily routines to overall well-being. While traditional methods such as therapy and medication remain essential, innovative solutions are expanding the options available to those in need. Wearable devices like Modius Stress represent a promising frontier, leveraging neuroscience to provide targeted, non-invasive relief for individuals with Generalized Anxiety Disorder.

In addition to cutting-edge technology, integrative treatment centers such as Avesta Ketamine Wellness are redefining the landscape of mental health care. By combining established therapeutic practices with emerging treatments, these centers offer comprehensive support tailored to the unique needs of each individual. As the conversation around mental health continues to evolve, accessible and effective solutions are becoming more crucial than ever.

The clearance comes on the heels of clinical trials that occurred in 2023 in the United Kingdom (UK) and Ireland and came shortly after Neurovalens got clearance for its Modius Sleep device, which can help treat insomnia. 

In addition to obtaining clearance, the company also announced that it secured additional funding totaling $2.65 million in preparation of Series B fundraising round, somewhere between $40 million and $50 million.