Fasikl’s FDA-cleared Felix™ NeuroAI™ Wristband represents a significant innovation at the intersection of neuromodulation, artificial intelligence, and wearable technology. As the first and only noninvasive, AI-powered therapeutic approved for essential tremor, Felix introduces a new category of smart bioelectronic medicine. Its cloud-connected platform continuously adapts stimulation based on user-specific needs and brain feedback—delivering a personalized, real-time therapeutic experience that evolves with the patient. This marks a shift from static, one-size-fits-all treatment models to dynamic, responsive care grounded in neuro-AI convergence.

Designed for adults living with essential tremor, a neurological condition that affects an estimated 7 million Americans, Felix offers a practical alternative to existing treatments. Traditional therapies—oral medications or invasive procedures like deep brain stimulation—often come with limited efficacy, unwanted side effects, or surgical risks. Felix, worn comfortably on the wrist, enables daily symptom relief without interrupting the user’s lifestyle. It integrates seamlessly into everyday activities, empowering users to regain control over tasks such as eating, writing, or dressing—areas often disrupted by tremor symptoms.

With its successful TRANQUIL clinical trial results, which demonstrated statistically significant improvements in motor function and daily activity performance, Felix is poised to reshape essential tremor care. Its clearance marks not only a major milestone for Fasikl but also a broader validation of AI therapeutics as a viable pathway for chronic neurological disorders. By making effective, personalized neuromodulation accessible, noninvasive, and scalable, Felix opens the door to a new era of intelligent wearable medicine—potentially extending this platform’s reach to other movement disorders in the near future.

MedTech Spectrum's Summary

First-of-its-kind AI-powered solution: Felix™ NeuroAI™ is the first FDA-cleared, noninvasive wearable device designed specifically for treating essential tremor—offering a personalized, intelligent neuromodulation alternative to traditional therapies.

Proven clinical efficacy: Supported by strong data from the TRANQUIL study, Felix significantly reduced tremors and improved patients’ ability to perform daily tasks—without the risks or complications of surgery or systemic drugs.

Transforming neuro care access: By combining AI adaptability, cloud connectivity, and wearable convenience, Felix represents a breakthrough in scalable, user-friendly care—paving the way for broader use of AI therapeutics in neurological conditions.