Sana Health Receives FDA De Novo Clearance for the Sana Device

On January 16, 2026, Sana Health received FDA De Novo clearance for the Sana Device, making it the first FDA-cleared audio-visual stimulator for neuropathic pain relief. The clearance establishes an entirely new medical device category — Audio-Visual Stimulator for Pain Relief (21 CFR 890.5775) — defined by Sana Health and recognized by the FDA.

The Sana Device is a prescription, non-invasive, drug-free wearable that delivers personalized light and sound stimuli to provide temporary relief of neuropathic pain in adults. It is cleared for use at home or in the clinic.

Peer-reviewed randomized controlled trials of the investigational Sana Device at institutions including Mount Sinai and MUSC demonstrate strong efficacy: a 67% responder rate for neuropathic pain, 82% clinically significant improvement in PTSD, and 70% above-responder rate for anxiety — with zero serious adverse events across all trials.

This milestone follows more than a decade of research, an FDA Breakthrough Device Designation in 2021, Health Canada approval in August 2025, and the treatment of over 2,000 patients across 14 clinical studies. As the first and only device in a regulatory category the company itself defined, Sana Health is bringing drug-free pain relief to the patients who need it most.