Encora wins FDA clearance for wrist-worn essential tremor treatment
MIT spinout Encora Therapeutics has received FDA 510(k) clearance for its wrist-worn device to relieve hand tremors in adults with essential tremor while it is being used. The vibration-based treatment follows trials in which more than 70% of participants experienced meaningful improvement, though Encora is still building sales capacity and seeking insurer coverage.
Bottom line — Encora’s next steps are production, sales and insurer coverage for a device cleared to relieve tremor during stimulation.
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MIT News reports that the project began as a 2017 student prototype; Encora became a company in 2020.
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Encora’s device applies mechanical vibration at the wrist to stimulate sensory receptors, according to co-founder Daniel Carballo, as described by MIT News.
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MIT News says a 2024 randomised trial involved 47 people with essential tremor; a later 59-person home-use trial also reported meaningful improvement for more than 70% of participants.
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NeuroFounders says the clearance is for symptom relief during stimulation, not lasting effects after the device is switched off.
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NeuroFounders places Encora X1 among a small group of FDA-cleared wrist-based tremor devices, alongside products from Cala Health and Fasikl.