Encora Therapeutics is a medtech company developing non-invasive neuromodulation for movement disorders, with an initial focus on essential tremor. Its lead product, Encora X1, is positioned as an on-demand, prescription wearable intended to provide symptom relief while stimulation is being delivered.
Encora X1 is a smartwatch-sized wrist wearable designed to sense tremor rhythm and deliver customized stimulation in response. The company describes a closed-loop approach where tremor signals are analyzed in real time and stimulation parameters are adjusted accordingly, aiming to disrupt tremor dynamics in the treated limb during active use.
Encora X1 is cleared for adults with essential tremor via the FDA 510(k) pathway, with the cleared indication specifying relief of hand tremors in the treated limb during stimulation. This places Encora within the FDA-cleared “external upper limb tremor stimulator” category alongside a small number of wrist-based peers, competing on labeling, workflow, and reimbursement execution rather than on a new regulatory class.