Fasikl, a neurotechnology company spun out of the University of Minnesota, has received FDA 510(k) clearance for its Felix™ NeuroAI™ Wristband, a noninvasive, AI-driven wearable designed to reduce upper limb tremors in adults with essential tremor (ET)—a condition affecting approximately 7 million people in the U.S.
Essential tremor is the most common movement disorder in the U.S., causing involuntary, rhythmic shaking—most often in the hands—that can make simple daily tasks like drinking from a glass, writing, or buttoning a shirt extremely difficult. Treatment options for essential tremor have traditionally been limited. Medications often provide inconsistent relief and are accompanied by undesirable side effects. More invasive solutions like deep brain stimulation and focused ultrasound can be effective but require surgical intervention, which may not be feasible or desirable for many patients, particularly older adults or those with comorbidities.
The Felix NeuroAI wristband reportedly represents a noninvasive alternative that offers a new level of personalization. Worn on the wrist, the device connects to Fasikl’s cloud-based AI platform, which enables continuous adaptation of stimulation based on neural signals captured from peripheral nerves. This allows the Felix device to deliver personalized therapy in real time, reportedly providing all-day symptom relief while integrating easily into a user’s daily life.
The FDA clearance was supported by strong clinical evidence from the TRANQUIL study, a randomized, double-blind, sham-controlled trial involving 125 adults across 12 clinical sites in the U.S. and China. Participants were assigned in a 2:1 ratio to receive either the Felix wristband or a sham device for 90 days. The study met its primary endpoint, demonstrating statistically and clinically significant reductions in tremors and improvements in daily activity performance. No serious device-related adverse events were reported. These results were presented at the American Academy of Neurology (AAN) annual meeting in April 2025.
Fasikl CEO Dr. Zhi Yang said the clearance “marks a defining moment for Fasikl and the millions of people living with essential tremor who have long been underserved by existing therapies.” He further noted that “this breakthrough in non-invasive, intelligent, and personalized neuromodulation marks the emergence of AI therapeutics in disease treatment,” offering “a new option that is potentially more effective, safer, and more scalable.”
The Felix NeuroAI Wristband will be available by prescription in select U.S. regions beginning in 2025, with national availability expected in 2026.
Tags
Artificial Intelligence (AI), Essential Tremor, FDA Approvals, Neuromodulation, Wearable Devices
