FDA Clears AI-Powered Wristband for Essential Tremor Relief
The FDA has approved the Felix NeuroAI Wristband, a wearable AI-driven neurostimulation device, for treating upper limb functional limitations in adults with essential tremor. The cloud-based system delivers personalized therapy, continuously adjusting stimulation throughout the day based on the patient’s needs.
“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.”
Essential tremor is the most common type of tremor disorder, affecting approximately 7 million people in the U.S., and is about seven times more common than Parkinson’s disease. It causes involuntary, rhythmic shaking, most often in the hands, which can make simple and everyday activities like drinking from a glass or tying shoelaces difficult. Traditional treatment options are limited, with oral medications providing inconsistent relief and often accompanied by undesirable side effects.4 Surgical interventions such as deep brain stimulation (DBS), while effective, require invasive procedures, carry surgical risks, and may not be suitable or desirable for all patients, particularly older adults or those with coexisting health conditions.
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