Nexalin to Begin FDA Trial for Insomnia Device
What happened
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.
Why it matters
- 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
Key numbers
- The 150-patient, triple-blinded, and sham-controlled study will be conducted in collaboration with Lindus Health.
What happens next
- The 150-patient, triple-blinded, and sham-controlled study will be conducted in collaboration with Lindus Health.
Quick answers
What happened in 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.
Why does Nexalin to Begin FDA Trial for Insomnia Device matter?
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
