Sana Health Receives FDA De Novo Clearance for Neuropathic Pain, Establishing a New Medical Device Category
Sana Health Receives FDA De Novo Clearance for Neuropathic Pain, Establishing a New Medical Device Category
In a significant regulatory milestone, Sana Health has received FDA De Novo clearance (DEN250005) for the Sana Device as an adjunctive treatment for the temporary relief of neuropathic pain in adults. The January 16, 2026 approval establishes an entirely new regulatory classification, Audio-Visual Stimulator for Pain Relief (21 CFR 890.5775), making Sana the first and only FDA-cleared device in this category.
The Sana Device is a prescription, non-invasive, drug-free medical device that delivers personalized light and sound stimulation through a lightweight wearable mask. Designed for use at home or in clinical settings, the device leverages over a decade of research in audio-visual neuromodulation to address complex chronic pain and behavioral health conditions. The FDA’s De Novo pathway underscores the novel nature of the technology, while its Class I designation enables accelerated hardware iteration and streamlined commercial deployment.
Clinical evidence supporting the device includes peer-reviewed randomized controlled trials conducted at leading institutions. Results demonstrated a 67 percent responder rate in neuropathic pain patients at Mount Sinai, 82 percent improvement in PTSD symptoms at MUSC and the VA, and 70 percent improvement in anxiety outcomes in a Department of Defense-funded study. All outcomes achieved statistical significance. These results position Sana at the intersection of pain management and behavioral health, two of the most pressing cost centers in modern healthcare.
This milestone follows a decade-long regulatory journey. Sana received FDA Breakthrough Device Designation in 2021 for fibromyalgia, secured Health Canada approval in August 2025, and has now achieved full U.S. De Novo clearance. With 600 devices already manufactured and ready for rollout, the company is launching across VA medical centers, oncology infusion pilots, and federal healthcare pathways, while building real-world evidence to support CMS reimbursement.
Commercial momentum is accelerating. Sana recently closed a 5 million dollar Series A extension round co-led by Noetic Fund and CarMa, with a strategic focus on validating reimbursement pathways ahead of a planned Series B raise. International expansion discussions are underway in Japan, and an ongoing PTSD and pain comorbidity study at Tel Aviv Sourasky Medical Center will further validate the company’s complex chronic care model, a framework particularly aligned with federal payers seeking long-term cost reduction.
More than 100 million Americans take daily prescription medication for pain and behavioral health conditions, representing over 600 billion dollars in annual healthcare costs. Demand for non-opioid and non-pharmaceutical alternatives continues to grow. Federal mandates such as the NoPain Act and expanded VA purchasing programs are accelerating adoption of innovative pain solutions.
As the first FDA-cleared audio-visual stimulator for pain relief, Sana Health now occupies a distinct position in a category it defined, offering a drug-free, scalable, and clinically validated alternative at a pivotal moment for healthcare innovation.
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