A New Wrist‑Worn Tool Helps People With Tremor Stay Independent
Encora Therapeutics has secured FDA approval for its wrist-sized device, the Encora X1, designed to treat essential tremor in adults. This clearance allows the product to be sold in the United States for this specific use.
Clinical Trials Support Effectiveness
The FDA's decision is backed by two clinical trials:
- A randomized, sham-controlled study comparing real stimulation to a placebo.
- A 90-day home-use study tracking patient progress.
Both trials demonstrated that users experienced reduced shaking and improved ability to perform daily tasks like eating, writing, and using a phone.
How the X1 Works
The Encora X1 detects a person’s tremor rhythm and delivers a tailored electrical signal to the wrist, disrupting unwanted movements. This allows patients to regain control over their hand movements.
- Lightweight and discreet, it fits seamlessly into daily life, similar to a smartwatch.
- Offers a non-invasive, drug-free alternative to medications and surgical options.
A Solution for Millions
With roughly seven million Americans suffering from essential tremor, the X1 addresses an unmet need for a non-surgical, drug-free treatment.
Encora’s team, composed of former MIT students, aims to empower patients with self-managed technology. The X1 represents a step toward regaining independence without surgery or long-term medication.
Next Steps
Following years of research and patient-centric design, the FDA clearance marks a significant milestone. Encora plans to make the X1 available through physicians as part of a comprehensive treatment plan.
Headquartered in Boston, Encora continues to develop innovative neuromodulation tools to improve the lives of those with movement disorders.
