Nexalin to Begin FDA Trial for Insomnia Device
Nexalin has announced the HALO™ Clarity Trial, a pivotal study to support a future De Novo submission to the FDA for its drug-free insomnia treatment. The 150-patient, triple-blinded, and sham-controlled study will be conducted in collaboration with Lindus Health. The company is targeting the multi-billion-dollar market for insomnia treatments.
- The device uses a proprietary technology called Deep Intracranial Frequency Stimulation (DIFS™), a 15 milliamp waveform engineered to modulate deeper neural circuits in the mid-brain associated with sleep regulation, unlike conventional transcranial therapies that primarily target cortical regions. - The De Novo pathway is the FDA's regulatory review process for novel, low-to-moderate-risk medical devices that lack a legally marketed predicate device; if successful, it creates a new device classification that can be used for future submissions. - This trial is fully decentralized, with participants using the device and completing assessments from home via Nexalin's NeuroCare virtual clinic platform, a model designed to increase
