Fasikl Receives FDA Clearance for Felix NeuroAI Wristband, the First and Only AI-Powered Treatment for Essential Tremor
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.
Fasikl Announces Breakthrough Pivotal Data Demonstrating Superiority of Felix NeuroAI Wristband over Sham Device for Essential Tremor
Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced that its pivotal TRANQUIL study met its primary endpoint of superiority for the company’s Felix™ NeuroAI™ wristband over a sham device. The Felix wristband significantly reduced tremors and showed statistically and clinically significant improvement in the users' ability to perform daily activities compared to those using the sham device.
Fasikl to Present Late-breaking Results From the Pivotal TRANQUIL Study of the Felix NeuroAI Wristband at the 2025 American Academy of Neurology Annual Meeting
Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced that results from the TRANQUIL pivotal study evaluating the efficacy and safety of the FelixTM NeuroAITM Wristband in patients with essential tremor (ET) will be presented at the Late-breaking Science session during the upcoming 2025 American Academy of Neurology (AAN) Annual Meeting in San Diego on April 8, 2025.
