FDA Clears AI-Powered Wrist Device for Essential Tremor

The US Food and Drug Administration has granted clearance to Encora Therapeutics for its Encora X1 wearable, developed to support people living with essential tremor (ET).

Encora X1 is a wrist-based neurostimulation system that uses artificial intelligence within a closed-loop framework to detect tremor patterns and deliver targeted electrical stimulation to peripheral nerves. By disrupting abnormal signals in real time, the device aims to enhance motor control and steadiness during everyday tasks.

The clearance decision was supported by findings from a randomised, sham-controlled clinical trial and a 90-day at-home study, both of which showed measurable improvements in tremor severity and functional activities such as writing and drinking.

Designed as a non-invasive and medication-free option, Encora X1 will be offered on a prescription basis once commercially available.

ET affects millions of Americans. Other cleared technologies in this field include devices from Fasikl and Insightec, reflecting continued growth in neuromodulation therapies.

16-02-2026