Fasikl Wins FDA Nod for Felix NeuroAI Wristband for Essential Tremor

Fasikl has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Felix NeuroAI wristband for tremor-related functional limitations in the upper limbs in adults with essential tremor.

Felix is a noninvasive, wearable device that connects to the company’s cloud-based artificial intelligence (AI) platform for continuous brain-AI co-adaptation and personalized therapy. It’s worn on the wrist and uses the cloud to dynamically adjust stimulation for all-day symptom relief while fitting into the wearer’s lifestyle.

The technology’s FDA nod was supported by data from the TRANQUIL study. Results showed the Felix wristband significantly reduced tremors and displayed improvement in users’ ability to perform daily activities compared to those using a sham device.

Efficacy was consistent across demographics, with no serious device-related adverse events reported.

“The Felix wristband represents a significant step forward in noninvasive, personalized treatment options for essential tremor,” said Rajesh Pahwa, M.D., Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, Director of the Movement Disorder Program at The University of Kansas Health System. “For many patients, current treatment options fall short—pharmaceutical treatments are helpful for less than 50% of the patients, and deep brain stimulation and focused ultrasound, while effective, require surgical intervention. This new AI wearable wristband backed by clinical evidence is an effective treatment option in patients with essential tremor.”

Felix NeuroAI will become available in select U.S. regions beginning this year, with nationwide availability anticipated in 2026.

“FDA clearance of Felix marks a defining moment for Fasikl and the millions of people living with essential tremor who have long been underserved by existing therapies,” said Zhi Yang, Ph.D., CEO of Fasikl. “This breakthrough in noninvasive, intelligent, and personalized neuromodulation marks the emergence of AI therapeutics in disease treatment. It offers a new option that is potentially more effective, safer, and more scalable. Our next step is to execute the commercialization plan to support Felix’s initial product launch.”