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Official announcements from Encora Therapeutics — FDA clearances, clinical trial results, leadership appointments, and company milestones. Our press releases are posted here as they're issued. For media inquiries and interview requests, contact Encora Therapeutics PR representative.
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Encora Therapeutics Receives FDA 510(k) Clearance for Encora X1™, a Breakthrough Wearable Device for Essential Tremor
Encora Therapeutics, a leader in non-invasive neuromodulation technology, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Encora X1™.
About Encora Therapeutics
Encora Therapeutics is a Boston-based medical device company developing non-invasive neuromodulation therapies for people living with movement disorders. Founded by graduates of the Massachusetts Institute of Technology, Encora combines neuroscience, engineering, and human-centered design to develop treatment options that fit into everyday life.
The company’s first product, Encora X1™, is an FDA-cleared, prescription wrist-worn device that uses mechanical neurostimulation to aid in the relief of hand tremors during stimulation in adults with essential tremor. Encora X1 can be used alongside medication or when first-line options have failed, weren’t tolerated, or were ruled out. With no electrical contraindications, it can also be considered for patients with implanted electrical devices and for patients who are not ready for, or are not appropriate candidates for, surgical options.