Cala Reports the US FDA Clearance of Cala kIQ Plus System for Essential Tremor and Parkinson’s Disease

Shots: The US FDA has granted clearance to Cala kIQ Plus system, a wearable neurostimulation device, for the treatment of action hand tremor in essential tremor (ET) & Parkinson's disease (PD) The Cala kIQ device provides temporary relief of hand tremors in adults with essential tremor & Parkinson’s disease, incl. postural & kinetic tremors, using transcutaneous…

ByRidhi Rastogi6 hours ago

NEWS

Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

Shots: The US FDA has granted 510(k) clearance to Encora X1 to help relieve hand tremors in the treated limb during stimulation in adults with essential tremor Clearance was backed by a sham-controlled trial & a 90-day home-use study, both demonstrating improvements in tremor severity & functional tasks, supporting the device’s ability to assist with…

ByRidhi RastogiFebruary 13, 2026

NEWS

Praxis Precision Medicines Reports the US FDA Breakthrough Therapy Designation of Ulixacaltamide for Essential Tremor

Shots: The US FDA has granted BTD to ulixacaltamide for the treatment of patients with essential tremor (ET) Designation was based on the topline data from the Essential3 program, consisting of Study 1 & 2, where in Study 1, ulixacaltamide improved mADL11 (1EP) by 4.3 points at Wk. 8, while Study 2 showed superior maintenance of…

ByRidhi RastogiDecember 30, 2025

NEWS

Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

Shots: The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026 Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved…

ByRidhi RastogiJuly 2, 2025

Cala Reports the US FDA Clearance of Cala kIQ Plus System for Essential Tremor and Parkinson’s Disease

Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

Praxis Precision Medicines Reports the US FDA Breakthrough Therapy Designation of Ulixacaltamide for Essential Tremor

Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

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