In 2017 a home renovator named Michael walked onto the stage of MIT's Kresge Auditorium and tried to draw a spiral. Early-onset Parkinson's had left his hands shaking so badly that he struggled to turn a screwdriver. Students from 2.009, MIT's product-design class, strapped their prototype to his wrist and pressed a button. One of them later described the device as a foamcore box with a Raspberry Pi inside and wires hanging out. Within seconds the tremor eased, Michael drew the spiral, and the packed auditorium roared. Afterward, people started asking the students where they could buy one.
This February the FDA cleared that prototype's descendant, the Encora X1, through the 510(k) pathway, and MIT News told the story this month as a class project that became a treatment. Nine years separate the two events. Part of that went to forming a company, running trials and waiting on review. The decisions that shaped those trials were about which patients the device would serve and what it would claim for them, and the demo on the Kresge stage answered neither.
What one evening proves
Michael's spiral showed that mechanical vibration at the wrist could quiet a tremor, in one person, for a few minutes, with the students at the controls. The spiral couldn't say which patients respond, how long the relief lasts, or whether people keep wearing the device at home once the novelty fades. The people asking where to buy one were reacting to what they had just watched, and asking for something that doesn't exist yet costs the asker nothing.
Encora changed patients
Encora started where the demo pointed. The students formed the company in 2020, and its first clinical trial, run in 2022 with Mass General Brigham, enrolled 20 people with Parkinson's. Then the team moved to essential tremor, a different condition that also shakes the hands. Daniel Carballo, a co-founder, gave MIT News the reason: it was a greater unmet need, and while Parkinson's has plenty of drugs in development, essential tremor hadn't seen the same innovation. That switch set who every later study would enroll and what it would measure.
The trials that followed were in essential tremor. Encora's announcement describes a randomized, sham-controlled trial and a 90-day home-use study; MIT News puts them at 47 and 59 patients, with more than 70 percent improving meaningfully in both. The cleared indication, per Encora, is a prescription wrist device that aids relief of hand tremors in the treated limb, during stimulation, in adults with essential tremor.
The phrase "during stimulation" limits the claim to relief while the device is running. That wording matched the evidence Encora had collected, and it now governs what Encora's reps can say in a neurologist's office. Choosing it was a product decision as much as a regulatory one, and I'd want the person who owns the product making it.
After clearance
MIT News reports that Encora is now building a national sales force, working to get insurers to cover the device, and ramping up production. A neurologist has to write the prescription, so a rep needs a clear account of which patients to send. Insurers will ask about cost and outcomes, evidence a clearance study wasn't designed to produce. And the factory has to make the thousandth unit behave like the handful that went through the trials.
Coverage is where the patient choice gets tested again. MIT News notes that one existing treatment for tremor involves drilling into the skull to place electrodes, and Encora's own materials position the X1 alongside medication or after first-line options fail. An insurer weighing the X1 against surgery will ask a different question from one weighing it against pills, and from the product seat the comparison I'd want settled first is which of those Encora leads with.
Dave's take
Carballo calls Encora's approach a platform and says Parkinson's is still the goal. I'd plan every condition on that list as its own indication, with its own trial and its own case to insurers, the way the X1 got cleared.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for product companies. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →