Showing 1171-1180 of 2689 results for "".
- FDA Approves Mirabegron for Neurogenic Detrusor Overactivity in Pediatric Patientshttps://practicalneurology.com/news/fda-approves-mirabegron-for-neurogenic-detrusor-overactivity-in-pediatric-patients/2469543/The Food and Drug Administration approved a new indication for mirabegron extended-release tablets (Myrbetriq; Silver Spring, MD) and mirabegron for extended-release oral suspension (Myrbetriq Granules; Silver Spring, MD) to treat neurogenic detrusor overactivity (NDO) in children age 3 yea
- FDA Grants Clearance to OneRF Trigeminal Nerve Ablation System for Facial Painhttps://practicalneurology.com/news/fda-grants-clearance-to-onerf-trigeminal-nerve-ablation-system-for-facial-pain/2483016/The Food and Drug Administration (FDA) has granted 510(k) clearance to the OneRF Trigeminal Nerve Ablation System (NeuroOne Medical Technologies Corporation [NeuroOne], Eden Prairie, MN), authorizing its use for the treatment of pain or for lesioning nerve tissue during neurosurgical procedures t
- Smartphone-Based Tremor Monitoring System For People with Parkinson’s Cleared by FDAhttps://practicalneurology.com/news/smartphone-based-tremor-monitoring-system-for-people-with-parkinsons-cleared-by-fda/2476039/The Food and Drug Administration (FDA) has granted 510(k) clearance to Neu Health’s (Oxford, England, United Kingdom) smartphone-based tremor assessment module. The device is designed to enable clinicians to remotely quantify tremor severity in adults with mild-to-moderate Parkinson disease (PD)
- FDA Clears Felix NeuroAI Wristband as First AI Wearable for Essential Tremorhttps://practicalneurology.com/news/fda-clears-felix-neuroai-wristband-as-first-ai-wearable-for-essential-tremor/2475519/The Food and Drug Administration has granted 510(k) clearance for the Felix NeuroAI Wristband (Fasikl, Minneapolis, MN), a novel transcutaneous peripheral nerve stimulation device to be used as a treatment for adults with essential tremor (ET). According to a statement from Fasikl, the clearance
- Plasma Biomarker Test to Aid in Alzheimer’s Diagnosis Cleared by FDAhttps://practicalneurology.com/news/plasma-biomarker-test-to-aid-in-alzheimers-diagnosis-cleared-by-fda/2474763/The Food and Drug Administration (FDA) has announced the 410(k) clearance of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (Fujirebio Diagnostics, Malvern, PA) to aid in the diagnostic evaluation of Alzheimer disease (AD), marking it the first in vitro diagnostic test for this disease state
- 3D CBCT Imaging Technology Receives FDA Clearance for Interventional Procedureshttps://practicalneurology.com/news/3d-cbct-imaging-technology-receives-fda-clearance-for-interventional-procedures/2474762/GE HealthCare (Chicago, IL) recently announced the Food and Drug Administration (FDA) 510(k) clearance and commercial launch of CleaRecon DL, a 3-dimensional (3D) reconstruction engine using machine learning designed to improve the quality of cone-beam CT (CBCT) images obtained during interventio
- Perfuze Zipline Access Catheters for Acute Ischemic Stroke Cleared by FDAhttps://practicalneurology.com/news/perfuze-zipline-access-catheters-for-acute-ischemic-stroke-cleared-by-fda/2473810/Perfuze (Galway City, Ireland), an Ireland-based developer of catheter-based aspiration technology for the treatment of acute ischemic stroke, announced that it has received FDA 510(k) clearance for its Zipline access catheters. In addition, Perfuze has secured €22 million in funding.
- Wrist-Worn Neurostimulation Device for Hand Movement Rehabilitation after Stroke or Spinal Injury Receives FDA Clearancehttps://practicalneurology.com/news/wrist-worn-neurostimulation-device-for-hand-movement-rehabilitation-after-stroke-or-spinal-injury-receives-fda-clearance/2473788/The Food and Drug Administration (FDA) has granted 510(K) clearance to NeuStim (Neuvotion, Stamford, CT), a noninvasive, surgery-free wearable neurostimulation device used to aid in hand movement recovery in patients who have experienced a stroke or spinal cord injury (SCI). The device can scan m
- The FDA Clears an EEG Point-of-Care Tool To Help Identify Seizures and Status Epilepticushttps://practicalneurology.com/news/the-fda-clears-an-eeg-decision-support-tool-that-identifies-seizure-and-status-epilepticus/2470661/The Food and Drug Administration (FDA) has granted 510(k) clearance to BrainWatch (Natus, Middleton, WI), an electroencephalography (EEG) decision support tool device, designed to rapidly identify nonconvulsive seizures and status epilepticus at point-of-care. Natus debuted BrainWatch at the Amer
- FDA Gives Nod to Automated Software for ARIA Monitoringhttps://practicalneurology.com/news/fda-gives-nod-to-automated-software-for-aria-monitoring/2470642/The Food and Drug Administration (FDA) has granted 510(k) clearance to Icobrain Aria (Icometrix, Boston, MA), a software that provides computer-assisted, automatic detection and severity grading for amyloid-related imaging abnormalities (ARIA). Icobrain Aria generates a quantitative summary repor