FDA Clears Encora Therapeutics’ Wearable Device for Essential Tremor

Encora Therapeutics has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the Encora X1. The authorization was supported by data from two clinical studies that demonstrated the product’s ability to consistently improve tremor severity and functional tasks during such daily activities as eating, drinking, and writing.

“The data demonstrate meaningful improvement in tremor severity and functional outcomes for patients with limited options,” said Ann Murray, M.D., principal investigator and chief of the WVU Rockefeller Neuroscience Institute (RNI) Comprehensive Movement Disorder Center. “For the 7 million Americans suffering from essential tremor (ET), 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.”

The Encora X1 is a noninvasive, wrist-worn neurostimulation device—roughly the size of a smart watch— designed to sense tremor rhythm and deliver a customized stimulation that disrupts the tremor signal, thus providing patients with stability and improved motor control during daily activities, such as drinking soup with a spoon, dialing a telephone, or plugging a cord into an electric outlet.

“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,” Encora Therapeutics Co-Founder/Business Operations Vice President Alli Davanzo stated. “Encora X1 offers a non-surgical, drug-free alternative, allowing patients to manage their symptoms on their own terms.”

The Encora X1 uses proprietary algorithms to analyze a patient’s tremor in real time. It delivers targeted stimulation to the wrist, modulating the neural pathways responsible for the tremor. The device is lightweight, discreet, and allows for seamless integration into daily life, according to the company.

“This clearance represents the culmination of rigorous research and patient-centric design,” Encora Therapeutics CEO Nadim Yared concluded. “We are eager to bring this solution to patients who have long waited for more options.”

Encora Therapeutics develops non-invasive solutions for movement disorders such as essential tremor. The company was founded by graduates of the Massachusetts Institute of Technology, and is headquartered in Boston.