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A wristband built in an MIT design class is now FDA-cleared for tremor

Encora Therapeutics grew out of a 2017 student project. Its vibrating wristband received FDA 510(k) clearance in February for adults with essential tremor.

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Key facts

What
Encora X1, a vibrating wristband for essential tremor
Clearance
FDA 510(k), February 2026
Origin
MIT class 2.009 project in 2017; company founded 2020
Evidence
two trials with 47 and 59 patients, over 70% improved

A vibrating wristband that three MIT students built for a product design class in 2017 is now an FDA-cleared treatment for adults with essential tremor, MIT News reported on October 2. The device, the Encora X1 from startup Encora Therapeutics, received 510(k) clearance in February.

The idea that almost lost the vote

The project started in 2.009, MIT's large product engineering class, where teams brainstorm dozens of ideas before picking one. Daniel Carballo suggested a wearable that would use mechanical vibration to calm tremors. His team chose it by 16 votes to 1, and the single vote against was his own, because he doubted it could be built in one semester.

The team trailed the rest of the class until, a week before final presentations, it met a man with early-onset Parkinson's disease. When he tried the prototype, his shaking eased so much that he agreed to repeat the demonstration on stage, where he drew a spiral, a standard tremor test, far more steadily with the device switched on.

How a buzz at the wrist reaches the brain

The wristband vibrates stretch receptors in the wrist, the sensors that tell the body where a limb is. According to Carballo, the resulting signals travel through peripheral nerves to the same brain regions that surgeons target with deep brain stimulation, which requires electrodes placed through the skull. The wristband aims for those regions without surgery.

From Parkinson's to essential tremor

The students formed the company in 2020 with help from MIT programs including Sandbox and the Venture Mentoring Service. A first trial in 2022 with 20 Parkinson's patients ran with Mass General Brigham, but the founders then shifted to essential tremor, which affects more people and has seen fewer new treatments.

A randomized trial with 47 essential tremor patients followed in 2024, and a 59-person study at home in 2025. In both, more than 70 percent of participants showed meaningful improvement, according to MIT News. Some patients wear the device 12 to 14 hours a day, Carballo said.

Encora is now building a sales team and seeking coverage from insurers. It still hopes to return to Parkinson's, the condition that inspired the class project. Pricing and insurance coverage have not been announced.

Sources

  1. Encora Therapeutics Receives FDA 510(k) Clearance for Encora X1
    Encora Therapeutics via Business Wire