Sana Health Receives FDA De Novo Grant for the Sana Device

On January 16, 2026, the FDA granted Sana Health's De Novo application for the Sana Device, making it the first FDA allowed audio-visual stimulator for neuropathic pain relief. The allowance 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. The pivotal sham-controlled randomized clinical trial leading to Sana's FDA De Novo clearance was conducted at Mount Sinai under the direction of Dr. David Putrino. Published in BMC Neurology, the study demonstrated that 67% of participants using the active Sana Device experienced clinically meaningful improvement in neuropathic pain symptoms (responder rate based on the Neuropathic Pain Symptom Inventory MCID), corresponding to a Number Needed to Treat (NNT) of 2.89. The most commonly prescribed medication for Neuropathic Pain, Lyrica, has an estimated NNT of 7.7, notably higher than that of the Sana Device. In addition, active Sana users showed significant reductions in pain medication use compared to sham, including a 15% decrease in opiates and a 78% decrease in anticonvulsants (exploratory analysis). Sana continues to pursue regulatory clearance for additional indications.

This milestone follows more than a decade of research, an FDA Breakthrough Device Designation in 2021, Health Canada approval for a neuropathic pain indication 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.