Latest news with #Fasikl
Yahoo
02-07-2025
- Health
- Yahoo
FDA approves Felix NeuroAI Wristband for essential tremor treatment
Fasikl has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Felix NeuroAI Wristband, designed to address tremor-related functional limitations in adults. Essential tremor affects around seven million people in the US, causing involuntary shaking that complicates daily tasks, according to the company. Traditional treatments, including medications and surgical options such as deep brain stimulation, often have limitations and risks. In contrast, the Felix wristband is a wearable, non-invasive device that connects to Fasikl's cloud-based AI platform, allowing for personalised therapy and continuous adjustment of stimulation. Fasikl CEO Zhi Yang said: '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 non-invasive, intelligent, and personalised neuromodulation marks the emergence of AI therapeutics in disease treatment. It offers a new option that is potentially more effective, safer, and more scalable.' The FDA clearance is supported by data from the TRANQUIL study, which demonstrated significant reductions in tremors and improvements in daily activities compared to a sham device. Fasikl presented the results at the American Academy of Neurology annual meeting in April 2025. The TRANQUIL study involved 125 adults across 12 clinical sites in the US and China, with participants randomly assigned in a 2:1 ratio to receive either the Felix NeuroAI wristband or a sham device for 90 days. The wristband will be available by prescription in select US regions starting in 2025, with availability across the country anticipated in 2026. Fasikl, a spin-off from the University of Minnesota, utilises its platform to capture neural signals from peripheral nerves for adaptive therapy. "FDA approves Felix NeuroAI Wristband for essential tremor treatment" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
01-07-2025
- Health
- Business Wire
Fasikl Receives FDA Clearance for Felix NeuroAI Wristband, the First and Only AI-Powered Treatment for Essential Tremor
MINNEAPOLIS--(BUSINESS WIRE)-- Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first-of-its-kind Felix™ NeuroAI™ Wristband for tremor-related functional limitations in the upper limbs in adults with essential tremor. '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. 1,2 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. 3 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. 4 Unlike surgical or pharmacologic interventions, Felix is a noninvasive, wearable device that effortlessly connects to Fasikl's cloud-based AI platform, enabling continuous brain-AI co-adaptation and personalized therapy. Worn on the wrist, it uses the cloud to dynamically adjust stimulation, offering all-day symptom relief while seamlessly fitting into the wearer's lifestyle. The FDA clearance of Felix is supported by compelling data from the TRANQUIL study, a randomized, double-blind, sham-controlled trial that met its primary endpoint. Results showed that the Felix wristband significantly reduced tremors and displayed statistically and clinically significant improvement in the users' ability to perform daily activities compared to those using the sham device ('placebo effect'). Efficacy was consistent across demographics, with no serious device-related adverse events reported. Results were presented as Late-breaking Science at the American Academy of Neurology annual meeting in April 2025, reinforcing Felix's safety and potential as a first-of-its-kind, noninvasive, AI-powered treatment. '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." The Felix NeuroAI Wristband will be available by prescription through healthcare providers in select U.S. regions starting in 2025, with nationwide availability expected in 2026. About Fasikl Based in Minneapolis, Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. A 2019 spin-off from the University of Minnesota, Fasikl leverages its proprietary platform to capture neural signals directly from peripheral nerves, enabling intelligent, adaptive therapy. The company is on a mission to transform the treatment landscape for movement disorders, paralysis, and other neurological impairments through cutting-edge neuromodulation innovations. Fasikl's portfolio includes the FDA-cleared Felix™ NeuroAI™ Wristband and the investigational Fasikl-X™ Nerve-Computer Interface. To learn more, visit References:
