Portable brain assessment device by Headsafe secures 510(k) FDA clearance

__ FDA Clears Nurocheck, Portable Device to Quickly Assess Brain Health (MS News Today): “A portable device that can quickly measure electrical activity in the brain and relay it to doctors via a smartphone app, called the Nurochek system, has been cleared by the United States Food and Drug Administration (FDA) for use as a medical device. Its developer, Headsafe, plans to it soon make this brain assessment system available for use with patients in the U.S., ages 14 and older.” The Announcement: Headsafe Announces FDA Clearance and U.S. Launch of its NUROCHEK Portable Brain Assessment System (press release): “HeadsafeIP Pty Ltd, a privately held brain health technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its NUROCHEK system for brain assessment and will immediately begin commercialization activities in the United States. The NUROCHEK system is intended for use in patients aged 14 years and older as indicator of brain function and is the world’s first portable Visual Evoked Potential (VEP) testing system for use at the point-of-care. The NUROCHEK system is a portable brain assessment device that provides an objective measure of brain function that utilizes VEPs. In under 3 minutes, the NUROCHEK system captures and transmits VEP stimulated Electroencephalography (EEG) data to a smartphone application for processing and secure cloud storage. Visual evoked potentials are used as a n...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Cognitive Neuroscience Health & Wellness Technology 510(k) clearance app brain brain health technology brain-assessment EEG electrical activity FDA Food and Drug Administration Headsafe neurological testing Nurochek portable Source Type: blogs

Related Links:

Authors: Bergland OU, Søraas CL, Larstorp ACK, Halvorsen LV, Hjørnholm U, Hoffman P, Høieggen A, Fadl Elmula FEM Abstract PURPOSE: The blood pressure (BP) lowering effect of renal sympathetic denervation (RDN) in treatment-resistant hypertension shows variation amongst the existing randomised studies. The long-term efficacy and safety of RDN require further investigation. For the first time, we report BP changes and safety up to 7 years after RDN, compared to drug adjustment in the randomised Oslo RDN study. MATERIALS AND METHODS: Patients with treatment-resistant hypertension, defined...
Source: Blood Pressure - Category: Hematology Tags: Blood Press Source Type: research
Authors: Zhang W, Xu JZ, Lu XH, Li H, Wang D, Wang JG Abstract PURPOSE: We hypothesise that dietary sodium intake interacts with serum uric acid to influence blood pressure (BP) in children and adolescents. In the present study, we investigated ambulatory BP in relation to hyperuricaemia, dietary sodium intake and their interaction in children and adolescents with hypertension. MATERIALS AND METHODS:  A total of 616 study participants were 10-24 years old and had primary hypertension diagnosed after admission in a specialised inpatient ward. Ambulatory BP monitoring was performed during hospitalisat...
Source: Blood Pressure - Category: Hematology Tags: Blood Press Source Type: research
Source: European Journal of Sport Science - Category: Sports Medicine Authors: Source Type: research
CONCLUSION: The proposed PHARMAC criteria will give access to these important drugs to those people with T2DM who will likely benefit the most. PMID: 33032305 [PubMed - in process]
Source: New Zealand Medical Journal - Category: General Medicine Tags: N Z Med J Source Type: research
Authors: Siamashvili M, Davis S Abstract INTRODUCTION: Bromocriptine mesylate quick release (QR) is a dopamine D2 receptor agonist and is the only oral, primarily centrally acting drug that can be used for the treatment of adults with type 2 diabetes. AREAS COVERED: The authors describe current recommendations on the use of bromocriptine mesylate QR. Major efficacy and safety parameters of the late phase trials, including The Cycloset Safety Trial, have been identified and presented. EXPERT OPINION: Efficacy of bromocriptine mesylate QR monotherapy appears to be low but is compensated by favorable safety pr...
Source: Expert Opinion on Pharmacotherapy - Category: Drugs & Pharmacology Tags: Expert Opin Pharmacother Source Type: research
Abstract Trace metals concentrations of 25 elements were determined for 22 subcomponents of biodegradable and non-biodegradable waste samples representing the United States municipal solid waste (MSW) stream collected during three separate waste sorts. The subcomponent trace metal concentrations and estimated composition results were used to predict trace metal concentrations present in the overall MSW stream along with MSW compost and waste to energy (WTE) ash, which were compared to health-based standards (i.e., US EPA regional screening levels) and to values previously reported in the literature. These estimate...
Source: Chemosphere - Category: Chemistry Authors: Tags: Chemosphere Source Type: research
Publication date: December 2020Source: Journal of Functional Foods, Volume 75Author(s): Tingting Wang, Lin Zheng, Tiantian Zhao, Qi Zhang, Zhitong Liu, Xiaoling Liu, Mouming Zhao
Source: Journal of Functional Foods - Category: Nutrition Source Type: research
Conclusion: Patients with isolated thalamic atrophy were at a higher risk for not reaching 2-year NEDA-3 and for EDSS increase than patients with no identified brain atrophy. The groups were clinically indistinguishable. A single measurement of thalamic and whole brain atrophy could help identify patients needing most effective therapies from early on. Introduction The quantification of brain atrophy by MRI has become an increasingly important part of evaluating neurodegeneration in MS (1, 2). Atrophy measures can reflect the damage on the central nervous system (CNS) caused by the pathological processes of the dis...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Conclusions: Comorbidity is more common than expected in MS, even around the time of diagnosis. The prevalence of psychiatric comorbidity is particularly high and highlights the need for clinical attention to this issue. The observed sex-specific differences in the burden of comorbidity in MS, which differ from those in the matched population, warrant further investigation.
Source: Neurology - Category: Neurology Authors: Tags: All Medical/Systemic disease, Multiple sclerosis, Cohort studies, Prevalence studies ARTICLE Source Type: research
Conclusions: Multiple physical comorbidities were associated with an increased incidence of depression, anxiety disorders and bipolar disorder in the MS and matched populations.Patterns of associations unique to MS may help identify common underlying mechanisms and novel treatment approaches to manage psychiatric comorbidities in MS. Study supported by: CIHRDisclosure: Dr. Marrie has received research support from the Canadian Institutes of Health Research, Multiple Sclerosis Society of Canada, National Multiple Sclerosis Society, Rx &D Health Research Foundation, Research Manitoba and sanofi-aventis. Dr. Patten has no...
Source: Neurology - Category: Neurology Authors: Tags: Risk Factors for Multiple Sclerosis Source Type: research
More News: Brain | Depression | Diabetes | Endocrinology | Epilepsy | Eyes | Food and Drug Administration (FDA) | Hypertension | Medical Devices | Medical Ethics | Multiple Sclerosis | Neurology | Neuroscience | Smokers | USA Health