Providers
Clinical Evidence
Rigorous Multicenter Clinical Evaluation
Felix NeuroAI™ was evaluated in a multi-region, multicenter clinical study that included a 90-day randomized, double-blind, sham-controlled phase, followed by a 270-day open-label extension to evaluate longer-term outcomes.2, 5
Note: Figure adapted from publications #2 and #5 listed below
FDA-Cleared Indication for Use
The Felix™ NeuroAI™ Wristband is indicated to aid in tremor-related functional limitations in the upper limbs in adults with essential tremor. Supported by clinical evidence, Felix’s indication is not limited to the treated hand or to temporary periods during or following stimulation.2, 3
Superior and clinically meaningful improvement at 90 days
During the randomized, double-blind phase, TETRAS mADL improved by 6.9 points with Felix compared with 2.7 points with sham (P < .0001). The 6.9-point improvement exceeded the 6.2-point threshold for clinically meaningful improvement, demonstrating a treatment effect that was both statistically significant and clinically meaningful.2, 4
Progressive improvement with continued treatment at 1 Year
Patients receiving Felix showed continued improvement, with TETRAS mADL improvement increasing from 6.9 points at 90 days to 9.7 points at 1 year. These longer-term results demonstrate sustained and progressively greater improvement with continued Felix treatment.5
Consistent benefit across patient populations
The 90-day treatment effect was consistent across key subgroups, including age, sex, tremor severity, family history of tremor, current ET medication use, and prior ET medication use.2
Broad patient benefit
Across clinical studies, tremor improvement was reported in approximately 70–80% of patients, based on rigorous clinical assessments that included both clinician and patient evaluations. Improvements were also observed in activity-related and psychosocial measures of quality of life.1, 2, 5
Benefit beyond the stimulated hand
Clinical studies showed that wearing a single Felix device can reduce tremor in both upper limbs, extending the therapeutic benefit beyond the stimulated hand.1, 2, 3
Favorable safety profile
No serious adverse device reactions were reported in the clinical studies. Mild skin irritation was the most commonly reported side effect.1, 2, 3, 5
Hear the Expert Voices
“One of the unmet needs in essential tremor is providing patients with good tremor control without compromising safety. Felix is a wearable device with built-in artificial intelligence that is shown to provide these benefits to ET patients whose tremor is affecting their daily activities.”
Rajesh Pahwa, MD
Laverne & Joyce Rider Professor of Neurology
Chief, Parkinson and Movement Disorder Division University of Kansas Medical Center
“[Fasikl] demonstrates, in these
studies, a reduction in tremor and
not having to pay the price of sys-
temic side effects or having to have
brain surgery. Fasikl opens a new door – a new approach and a new product to help patients.”
Stuart H. Isaacson, MD
Director, Parkinson’s Disease and Movement Disorders Center of Boca Raton
“Overall, our patients were very favorable towards [Felix]. They almost all felt that there was improvement in the tremor, and it continued over time.”
William Ondo, MD
Director- Methodist Neurological Institute Movement Disorders Clinic and Fellowship Program
Prof. Neurology, Weill Cornell Medical School
Adjunct Prof. of Clinical Education, Neurology, Texas A&M Medical School
“Essential tremor is one of the most common neurological disorders in the world. Unfortunately, much about the disease remains unknown, and current medications often yield disappointing results. As a result, many diagnosed patients are left without effective treatment options. Felix leverages AI to optimize stimulation patterns, and with properly trained algorithms, it can significantly enhance treatment outcomes.”
Richard B. Dewey Jr., MD
Medical Director, Fasikl
Former Professor of Neurology
Former Director, Clinical Center for Movement Disorders
UT Southwestern Medical Center
“The ability to personalize therapy using AI technology is a major breakthrough. One of our board members tried the device and experienced tremendous benefit. Compared to other wearables, Felix is subtle – similar in appearance to an Apple Watch – and doesn’t make users feel different from others. Felix gives people hope; when medication fails, it offers a meaningful alternative.”
Patrick McCartney
Executive Director, International Essential Tremor Foundation
Publications and Presentations
Felix clinical studies have been published in the following peer-reviewed medical journals and presented at the following conferences:
Getting Started
Prescribing Felix NeuroAI™
Please select the appropriate coverage type below to view the required steps and documents.
- Review the criteria for Medicare coverage and the corresponding guidance on medical record documentation.
- Verify the patient meets ALL criteria and that every criterion is documented in the medical record. NOTE: If the patient does not meet the Medicare criteria but wants to pay for Felix out-of-pocket, please switch to the Non-Medicare prescription.
- Complete the Standard Written Order (SWO).
- Send the completed SWO and ALL relevant Medical Records to Fasikl Medical Solutions (Fax: 800-673-3999).
*Medicare requires a follow-up evaluation 60-91 days after the Felix fitting. We strongly recommend scheduling it 60-75 days after the fitting. We will notify you of the fitting date.
- Complete the Prescription Form.
- Send the Prescription Form to Fasikl Medical Solutions (Fax: 800-673-3999).
Make a Reservation Today
For New Patient Referrals
Have a patient who could benefit from Felix NeuroAI™? Let us help you and your patient navigate the path to treatment.
You can begin the process by asking them to make a reservation. We will contact the patient to help them with onboarding and work with your staff to ensure all necessary prescription and documentation is completed efficiently.
Having any Questions or Feedback?
Please contact our support team.
