Encora Therapeutics, developer of non-invasive neuromodulation tech, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Encora X1.

Encora X1 is a non-invasive, wrist-worn neuromodulation device about the size of a smartwatch. It’s designed to sensor tremor rhythm and deliver customized stimulation that disrupts the tremor signal, offering patients stability and motor control during daily activities—drinking soup with a spoon, dialing a telephone, or plugging a cord into an electrical outlet.

The clearance was supported by data from two clinical studies: a randomized, sham-controlled trial and a 90-day home-use study. Together, the studies showed consistent improvements in tremor severity and functional tasks, demonstrating the device’s ability to help with daily activities like eating, drinking, and writing.

“The data demonstrate meaningful improvement in tremor severity and functional outcomes for patients with limited options,” said Ann Murray, MD, principal investigator and chief of the WVU Rockefeller Neuroscience Institute (RNI) Comprehensive Movement Disorder Center. “For the 7 million Americans suffering from essential tremor, medications are often ineffective or poorly tolerated, leaving invasive brain therapy as the only alternative. Non-invasive technologies like this represent an important area of innovation in the treatment of essential tremor.”

This FDA nod authorizes commercial marketing of Encora X1 as a prescription wearable device to help with relief of hand tremors in the treated limb during stimulation in adults with essential tremor (ET).

“We started Encora with a simple goal: to restore independence for movement disorder patients. Today, we are one step closer to making that vision a reality,” said Alli Davanzo, Encora’s co-founder and VP of business operations. “Encora X1 offers a non-surgical, drug-free alternative, allowing patients to manage their symptoms on their own terms.”

The company first earned FDA breakthrough device status for its tremor reduction wearable in 2021.