The Food and Drug Administration (FDA) has granted clearance for the Felix™ NeuroAI™ Wristband to treat tremor-related functional limitations in adults with essential tremor. This innovative wearable device offers a new therapeutic option designed to reduce upper limb tremors and improve daily functioning.
How the Felix NeuroAI Wristband Works
The wristband uses a transcutaneous neurostimulation technique powered by a proprietary artificial intelligence (AI) algorithm. This cloud-based system continuously monitors and adjusts stimulation throughout the day, tailoring therapy to each patient’s specific needs. As a result, it delivers personalized, real-time relief from tremors in the upper limbs.
Clinical Evidence Supports Effectiveness
The FDA’s decision followed compelling data from the TRANQUIL study (ClinicalTrials.gov Identifier: NCT06235190), a randomized, double-blind, sham-controlled trial involving 125 adults diagnosed with essential tremor. Participants were randomly assigned in a 2:1 ratio to wear either the Felix NeuroAI Wristband or a sham device during waking hours for 90 days.
The study’s primary goal was to measure changes in the modified Activities of Daily Living (mADL) score, which ranges from 0 to 52, based on the Tremor Research Group Essential Tremor Rating Assessment Scale. According to MPR Daily Dose, results demonstrated that the Felix wristband significantly reduced tremors and improved daily activity performance compared to the sham device—showing a mean mADL score reduction of 6.9 points versus 2.7 points (P < .0001).
Consistent Benefits Across Patient Groups
Importantly, nearly 67% of patients using the Felix wristband experienced at least a 20% improvement in mADL scores, compared with only 25% in the sham group. This therapeutic effect remained consistent regardless of age, gender, tremor severity, or concurrent use of essential tremor medications. Fasikl Inc., the device manufacturer, also reported that participants with bilateral tremors benefited in both hands from wearing a single wristband.
Additional Improvements and Safety Profile
Beyond the primary endpoint, users of the Felix device saw improvements in secondary outcomes such as clinician-reported assessments, patient feedback, and quality of life measures when compared to the sham group. The safety profile was reassuring, with no serious adverse events reported. Mild skin irritation emerged as the most common side effect.
Industry Response and Future Outlook
Zhi Yang, PhD, CEO of Fasikl, commented on the approval: “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. 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.”