Showing 981-990 of 1043 results for "".
- FDA Clears Artificial Intelligence-Assisted Imaging System for Cerebral Aneurysm Detectionhttps://practicalneurology.com/news/fda-clears-artificial-intelligence-assisted-imaging-system-for-cerebral-aneurysm-detection/2469835/The Food and Drug Administration (FDA) gave 510(k) clearance for an artificial intelligence (AI) solution (Viz Aneurysm; Viz.ai, San Francisco, CA) for cerebral aneurysm detection. This imaging solution uses an algorithm to analyze brain imaging and identify cerebral aneurysms, to ensure pa
- A Synthetic Derivative of Squalamine Restored the Function of Enteric Nerve Cells in Parkinson Diseasehttps://practicalneurology.com/news/a-synthetic-derivative-of-squalamine-restored-the-function-of-enteric-nerve-cells-in-parkinson-disease/2469810/In the phase 2b KARMET study, participants (n=150) with Parkinson disese (PD) and constipation treated with a synthetic derivative of squalamine (ENT-01; Enterin Inc, Philadelphia, PA) vs placebo had restored the function of enteric nerve cells. The change in complete spontaneous bowel movement (
- FDA Approves Daridorexant for Insomniahttps://practicalneurology.com/news/fda-approves-daridorexant-for-insomnia/2469795/The Food and Drug Administration (FDA) approved daridorexant (Quviviq; Idorsia, Radnor, PA) for insomnia treatment. In the phase 3 clinical program, daridorexant demonstrated significant improvement in insomnia compared with placebo based on objective measures of sleep onset, sleep maintenance, r
- FDA Grants Orphan Drug Exclusivity for Mixed Salts Oxybate for Cataplexy or Excessive Daytime Sleepinesshttps://practicalneurology.com/news/fda-grants-orphan-drug-exclusivity-for-mixed-salts-oxybate-for-cataplexy-or-excessive-daytime-sleepiness/2469624/The Food and Drug Administration has granted 7 years of Orphan Drug Exclusivity for mixed salts oxybate (Xywav; Jazz Pharmaceuticals, Philadelphia, PA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) caused by narcolepsy in individuals age 7 years or more. FDA
- Effect Size and Number Needed to Treat Suggest Pitolisant Be Considered for First-Line Therapy of Narcolepsyhttps://practicalneurology.com/news/effect-size-and-number-needed-to-treat-suggest-pitolisant-be-considered-for-first-line-therapy-of-narcolepsy/2469612/Post hoc analysis of data from clinical trials of pitolisant (Wakix; Harmony Biosciences, Plymouth Meeting, PA) shows a robust effect size with a low number needed to treat (NNT) (Table). These results suggest pitolisant may be considered for first-line treatment of excessive daytime sleepiness (
- FDA Gives Marketing Authorization to Translingual Neuromodulation Device for Treatment of Gait Deficits in Multiple Sclerosishttps://practicalneurology.com/news/fda-gives-marketing-authorization-to-translingual-neuromodulation-device-for-treatment-of-gait-deficits-in-multiple-sclerosis/2469546/The Food and Drug Administration (FDA) authorized marketing of a tongue-delivered portable neuromodulation device (PoNS; Helius Medical, Newtown, PA) to treat gait deficit caused by multiple sclerosis (MS). The device is a prescription only adjunct to a supervised therapeutic exercise program for
- Supplemental New Drug Application Submitted for Mixed-Salt Oxybates for Idiopathic Hypersomnia Treatmenthttps://practicalneurology.com/news/supplemental-new-drug-application-submitted-for-mixed-salt-oxybates-for-idiopathic-hypersomnia-treatment/2469501/A supplemental new drug application (sNDA) has been submitted to the Food and Drug Administration (FDA) for marketing approval of the mixed calcium, magnesium, potassium, and sodium oxybates (Xywav; Jazz Pharmaceuticals, Philadelphia, PA) oral solution for treatment for adults with idiopathic hyp
- Cerebrospinal Fluid Amyloid Tests A Step Closer to Use in Day-to-Day Practicehttps://practicalneurology.com/news/cerebrospinal-fluid-amyloid-tests-a-step-closer-to-use-in-day-to-day-practice/2469446/An application has been made to the Food and Drug Administration (FDA) for clearance of a device (Lumipulse G1200; Fujirebio Diagnostics, Malvern, PA), already granted breakthrough designation by the FDA, for measurement of amyloid-ß ratios in cerebrospinal fluid (CSF). If cleared, this wou
- Pitolisant Treatment Improves Excessive Daytime Sleepiness and Reduces Cataplexy in Narcolepsyhttps://practicalneurology.com/news/pitolisant-treatment-improves-excessive-daytime-sleepiness-and-reduces-cataplexy-in-narcolepsy/2469371/Three post-hoc analyses of the efficacy and safety data for pitolisant (WAKIX; Harmony Biosciences Holding, Plymouth Meeting, PA) showed improvement in excessive daytime sleepiness (EDS) and reduction in cataplexy occurred with pitolisant vs placebo treatment. In 2 studies, Harmony 1 (<
- FDA Approves New Oxybates Compound for Cataplexy or Excessive Daytime Sleepiness of Narcolepsyhttps://practicalneurology.com/news/fda-approves-new-oxybate-compound-for-cataplexy-or-excessive-daytime-sleepiness-of-narcolepsy/2469330/The Food and Drug Administration (FDA) approved a calcium, magnesium, potassium, and sodium oxybates oral solution (Xywav; Jazz Pharmaceuticals, Philadelphia, PA) on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in individuals age 7 years and more with n