FDA clears first AI-driven wristband for essential tremor relief

Felix NeuroAI wristband designed to provide tremor relief: ©Fasikl

The U.S. Food and Drug Administration has granted 510(k) clearance for the Felix NeuroAI Wristband, a noninvasive, AI-powered device designed to reduce tremor-related functional limitations in adults with essential tremor, neurotechnology company Fasikl announced.

The wristband, which connects to a cloud-based platform to deliver personalized, adaptive stimulation, is the first of its kind to receive FDA clearance for essential tremor. The device provides continuous therapy throughout the day without the need for surgery or pharmaceuticals.

“The Felix wristband represents a significant step forward in noninvasive, personalized treatment options for essential tremor,” said Rajesh Pahwa, professor of neurology at the University of Kansas School of Medicine. “Pharmaceutical treatments are helpful for less than 50% of the patients, and deep brain stimulation and focused ultrasound, while effective, require surgical intervention.”

Essential tremor affects roughly seven million people in the U.S.—about seven times more than Parkinson’s disease—and can severely interfere with daily activities like drinking or writing. Existing treatments, such as oral medication or brain surgery, often present challenges, including limited effectiveness or potential risks.

The FDA clearance was based on results from the TRANQUIL study, a randomized, double-blind, sham-controlled trial. Data showed that users of the Felix device had significantly reduced tremors and improved function in daily tasks, with no serious device-related side effects. Fasikl expects the device to be available by prescription in select U.S. regions in 2025, with full national rollout anticipated in 2026.

Advances in noninvasive neuromodulation offer new hope for movement disorders

The field of bioelectronic medicine is undergoing a transformation with the emergence of noninvasive neuromodulation devices, many of which incorporate artificial intelligence to tailor therapy to individual users. These wearable or minimally intrusive technologies aim to address neurological disorders like essential tremor, Parkinson’s disease, and dystonia—conditions that have traditionally been treated with drugs or invasive procedures.

Recent innovations focus on wearable systems that use targeted electrical or mechanical stimulation to modulate neural activity. Unlike medications, which can produce side effects and often lose effectiveness over time, or surgical techniques like deep brain stimulation, which carry inherent risks, wearable neuromodulation devices offer safer, more accessible alternatives.

Artificial intelligence has played a central role in enhancing the effectiveness of these devices. Through continuous data collection and analysis, AI can adapt stimulation patterns in real time, increasing therapeutic precision. Cloud connectivity enables these systems to learn from user interactions and improve performance with ongoing use, allowing for personalized neurotherapeutics.

Ongoing clinical studies are increasingly validating the efficacy of these approaches. Researchers are especially interested in how such devices can support long-term quality of life improvements and reduce the health care burden associated with chronic neurological disorders. While challenges remain—including cost, access, and reimbursement—noninvasive neuromodulation powered by AI is emerging as a viable and promising frontier in treating movement disorders and beyond.