Background image

Encora Therapeutics Receives FDA 510(k) Clearance for Encora X1™, a Breakthrough Wearable Device for Essential Tremor

BOSTON–(BUSINESS WIRE)–Encora Therapeutics, a leader in non-invasive neuromodulation technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Encora X1™. This clearance is supported by data from two clinical studies: a randomized, sham-controlled trial and a 90-day home-use study. Together, these studies demonstrated consistent improvements in tremor severity and functional tasks, showcasing . . .