Showing 1211-1220 of 2843 results for "".
- FDA Clears Brain–Computer Interface Device for the Measurement and Stimulation of Cortical Brain Activityhttps://practicalneurology.com/news/fda-clears-braincomputer-interface-device-for-the-measurement-and-stimulation-of-cortical-brain-activity/2474229/The Food and Drug Administration (FDA) has granted 510(k) clearance to the Layer 7 Cortical Interface device (Precision Neuroscience, New York Ci
- New CSF Assays to Measure Beta-Amyloid and Tau Receive Clearance from FDAhttps://practicalneurology.com/news/new-csf-assays-to-measure-beta-amyloid-and-tau-receive-clearance-from-fda-1/2470232/Roche (Basel, Switzerland) announced that the US Food and Drug Administration (FDA) has issued 501(k) clearance to assays that measure 2 biomarkers, beta-amyloid and tau proteins, used to evaluate Alzheimer disease (AD) pat
- Barancik Prize Awarded to Dr. Ruth Ann Marrie at ACTRIMS 2023https://practicalneurology.com/news/barancik-prize-awarded-to-dr-ruth-ann-marrie-at-actrims-2023/2470120/The National Multiple Sclerosis Society announced that Ruth Ann Marrie, MD, P
- Fenfluramine May Usher in Higher Standards for Treatment of Dravet Syndromehttps://practicalneurology.com/news/fenfluramine-may-usher-in-higher-standards-for-treatment-of-dravet-syndrome/2469642/In an editorial in Epilepsy and Behavior, Helen Cross, MD and Joseph Sullivan, MD suggest fenfluramine (Fintepla; Zogenix, Emeryville, CA) clinical trial results can raise the bar for efficacy of antiseizure medications (ASMs) for
- Award Recipients Recognized at the 2024 International Congress of Parkinson’s Disease and Movement Disordershttps://practicalneurology.com/news/award-recipients-recognized-at-the-2024-international-congress-of-parkinsons-disease-and-movement-disorders/2470598/The International Parkinson’s Disease and Movement Disorders Society (MDS) has announced recipients of the 2024 MDS Awards. The awards honor professionals in the field who are elevating care for movement disorders through their contributions to research, scholarship, and clinical work. The
- 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 Clears Automated Cerebrospinal Fluid Drainage and Intracranial Pressure Monitoring Devicehttps://practicalneurology.com/news/fda-clears-automated-cerebrospinal-fluid-drainage-and-intracranial-pressure-monitoring-device/2485198/The Food and Drug Administration (FDA) has granted 510(k) clearance for Intellidrop (BrainSpace, Seattle, WA), an automated brain fluid management system for use in cerebrospinal fluid (CSF) drainage and intracranial pressure (ICP) monitoring. The device integrates proprietary hardware and softwa
- Two New Aspiration Devices Receive FDA Clearance for Peripheral and Neurovascular Thrombectomyhttps://practicalneurology.com/news/two-new-aspiration-devices-receive-fda-clearance-for-peripheral-and-neurovascular-thrombectomy/2484506/The Food and Drug Administration (FDA) has granted 510(k) clearance to 2 devices developed by Vesalio (Plano, TX) designed to be used for aspiration during thrombectomy in the peripheral or neurovascular arterial setting. Although the names of the devices were not detailed in a press release issu
- Blood-Based P-Tau181 Testing for Alzheimer’s Pathology Now Cleared by the FDA for the Primary Care Settinghttps://practicalneurology.com/news/blood-based-p-tau181-testing-for-alzheimers-pathology-now-cleared-by-the-fda-for-the-primary-care-setting/2484309/The Food and Drug Administration (FDA) has granted 510(k) clearance to Elecsys pTau181 (Roche, Basel, Switzerland), the first blood-based biomarker assay authorized to aid in the initial assessment of Alzheimer disease (AD) and other causes of cognitive decline for people aged ≥55 years in the pr
- FDA Clears AI Software Tool for Automated Detection of LVOs from CT Angiographyhttps://practicalneurology.com/news/fda-clears-ai-software-tool-for-automated-detection-of-lvos-from-ct-angiography/2484230/The Food and Drug Administration has granted 510(k) clearance to Methinks CT Angiography (CTA) Stroke (Methinks Software, Barcelona, Spain), an artificial intelligence–driven software that detects large vessel occlusions (LVOs) using CTA scans. According to a statement from the company, Methinks