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Thursday, January 10, 2019

Eye-Movement Tracker Approved for Diagnosing Concussion

The Food and Drug Administration has granted a de novo request for marketing authorization of an algorithm-driven eye-movement tracking system (Eyebox; Oculogica, New York, NY) for the diagnosis of co…

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Wednesday, January 09, 2019

Breakthrough Device Designation Granted to Brain-Monitoring Technology

The Food and Drug Administration has granted breakthrough device designation to a brain health monitoring technology (Neurametrix; San Francisco, CA). The approved use is monitoring Parkinson’s …

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Tuesday, January 08, 2019

Phase 3 Trial of Dioscorea japonica Extracts To Be Initiated for Treatment of Pain From Diabetic Neuropathy

The planned initiation of a phase 3 double-blind, placebo controlled, 12-week study of Dioscorea japonica extracts (NB-01; Neurobo, Boston, MA) for pain relief in patients with diabetic neur…

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Tuesday, January 08, 2019

FDA Clears First-in-Class NonEEG, Seizure-Monitoring, Wearable Device for Children

The Food and Drug Administration (FDA) has granted 510(k) clearance for a wearable smartband device (Embrace; Empatica, Boston, MA) to detect seizure activity in children age 6 years and up. This smar…

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Tuesday, January 08, 2019

New Aneurysm Treatment Device Receives Premarket Approval

The Food and Drug Administration (FDA) granted premarket approval (PMA) to an intrasaccular flow disruptor (Web aneurysm embolization system; Microvention, Aliso Viejo, CA) which is a single-device tr…

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Friday, January 04, 2019

Inebilizumab Meets Primary and Secondary Endpoints for Treatment of Neuromyelitis Optica Spectrum Disorder

In a global trial of inebilizumab (Viela Bio, Gaithersberg, MD) for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD), the drug met its primary and secondary endpoints. The…

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Thursday, January 03, 2019

American Academy of Neurology Call for Uniformity in Brain Death Standards

Noting that only 1 state, Nevada, has adopted legislation requiring use of medically accepted guidelines for determining brain death, the American Academy of Neurology (AAN) is calling for action on t…

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Wednesday, January 02, 2019

The Cost of Caring: Those Who Care for Loved Ones with Parkinson’s Lose Income Too

In a study published in the journal Movement Disorders, researchers studied the economic impact of caring for someone with Parkinson’s disease (PD) in the first 5 years of diagnosis. Previo…

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Wednesday, January 02, 2019

New Drug Application Accepted for Combined Bupivacaine/Meloxicam for Post-Operative Pain

The Food and Drug Administration (FDA) has accepted a new drug application (NDA) for fixed-dose combined bupivacaine/meloxicam (HTX-011; Heron Therapeutics, San Diego, CA), an investigational, extende…

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Friday, December 28, 2018

Reliability of Ultrasound Measurements in Patients with Amyotrophic Lateral Sclerosis

In a study published in the journal Muscle & Nerve, researchers suggest diagnostic ultrasound may provide a reliable biomarker for amyotrophic lateral sclerosis (ALS). This study used ultraso…

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Wednesday, December 26, 2018

Levodopa Inhalation Powder for Treatment of OFF Periods of Parkinson’s Approved

The Food and Drug Administration (FDA) has approved levodopa inhalation powder (Inbrija; Acorda Therapeutics, Ardsley, NY) for the intermittent treatment of OFF episodes in patients with Parkinson&rsq…

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Wednesday, December 26, 2018

Study Defines Risk Factors for REM Sleep Behavior Disorder

A study published in Neurology online found that taking antidepressants for depression or having anxiety or post-traumatic stress disorder (PTSD) are correlated with the disruptive and somet…

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Tuesday, December 18, 2018

New Drug Application Submitted for Therapy for Multiple Sclerosis

A New Drug Application (NDA) has been submitted to the US Food and Drug Administration (FDA) for diroximel fumarate (BIIB098/Vumerity; Alkermes PLC, Waltham, MA), a novel oral fumarate in development …

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Monday, December 17, 2018

Sleep Apnea Can Double Risk of Hard-to-Treat Hypertension in African-Americans

A new study published in Circulation reveals that African-Americans with moderate or severe sleep apnea are twice as likely to have hard-to-control high blood pressure when their sleep apnea…

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Thursday, December 13, 2018

Long-Term Safety and Tolerability of Rimegepant for Treatment of Migraine

Initial results from an ongoing, open-label safety study of the oral calcitonin gene-related peptide (CGRP) receptor antagonist, rimegepant, show that the drug may be effective and safe for acute trea…

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