Encora Therapeutics has earned FDA approval for its wrist‑sized device, the Encora X1, which can be prescribed to adults who suffer from essential tremor. The clearance means the product can now be sold in the United States for this specific use.

Clinical data from two trials support the decision. One was a randomized, sham‑controlled study that compared real stimulation to a fake one, while the other followed patients for 90 days in their own homes. Both studies showed that users experienced less shaking and could perform everyday tasks—like eating, writing, or using a phone—more smoothly.

The X1 works by detecting the rhythm of a person’s tremor and delivering a tailored electrical signal to the wrist. This “disrupts” the unwanted movement, giving patients more control over their hand movements during normal activities. It is designed to be lightweight and discreet, fitting into a daily routine much like a smartwatch.

The device offers an alternative to medications that often fail or cause side effects, and it is non‑invasive compared with surgical options. Experts say that for the roughly seven million Americans who have essential tremor, a drug‑free, non‑surgical solution could fill an unmet need.

Encora’s team, made up of former MIT students, has focused on creating technology that patients can manage themselves. The company claims the X1 is a step toward allowing people with movement disorders to regain independence without surgery or long‑term drugs.

The FDA clearance is a milestone that follows years of research and patient‑centric design. Encora plans to make the device available through physicians who can prescribe it as part of a broader treatment plan.

The company’s headquarters are in Boston, and it continues to develop new neuromodulation tools aimed at improving quality of life for those with movement challenges.

A New Wrist‑Worn Tool Helps People With Tremor Stay Independent

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