+5 | The top 5 medtech stories for June 17, 2016

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. EU Council &Parliamentary councils signs off on new med device, IVD regs The Environment, Public Health and Food Safety Committee of the European Parliament and Council’s Committee of Permanent Representatives voted yesterday to endorse new medical device and in vitro diagnostic regulations, according to MedTech Europe. The approval paves the way for for the adoption of 2 new draft regulations by the end of 2016, though the new rules would not take effect for 3 years in relation to medical devices and 5 years for IVD. Read more 4. EndoGastric Solutions wins nod from medical society for Esophyx anti-GERD device The American Gastroenterological Assn. recommended that insurers cover the Esophyx device for treating gastroesophageal reflux disease made by EndoGastric Solutions. Citing the data from a quartet of randomized, controlled trials, the AGA said transoral incisionless fundiplication with Esophyx ought to be reimbursed for the 20% to 40% of GERD patients who don’t respond to medication. Read more 3. FDA OKs epilepsy trial for MDT’s Visualase...
Source: Mass Device - Category: Medical Equipment Authors: Tags: News Well Plus 5 Source Type: news

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Conclusions: Almost one-third of ASD patients in our sample had at least one fGID. The presence of fGID was associated with ID, sleep problems and with behavioral problems (as measured by the prescription of psychotropic drugs). This subsample of ASD patients with fGID deserves particular attention in future research projects, focusing on specific phenotypic characteristics and overlapping biological markers that may underlie both pathologies. Introduction Autism spectrum disorder (ASD) is a pervasive neurodevelopmental disorder characterized by impairments in social communication and restricted, repetitive patterns ...
Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
Sudden unexpected deaths in epilepsy have proven difficult to unravel. A recent study concludes that they might be driven by acid reflux.
Source: Health News from Medical News Today - Category: Consumer Health News Tags: Epilepsy Source Type: news
ConclusionSelf-reporting and clinical scrutiny are complementary. Structured questionnaires increase the range of predictive variables and should be utilized routinely to facilitate clinicians' quest for the correct diagnosis.
Source: Epilepsy and Behavior - Category: Neurology Source Type: research
CONCLUSION: Self-reporting and clinical scrutiny are complementary. Structured questionnaires increase the range of predictive variables and should be utilized routinely to facilitate clinicians' quest for the correct diagnosis. PMID: 30578096 [PubMed - as supplied by publisher]
Source: Epilepsy and Behaviour - Category: Neurology Authors: Tags: Epilepsy Behav Source Type: research
CONCLUSION Our present study has shown that Compunds 6, 5, 17, 11 exhibited IC50 values of 0.0006 ± 0.0002, 18.91 ± 0.005, 19.18 ± 0.002, 36.91 ± 0.003 μM, respectively. The studies were supported by in silico data analysis. PMID: 30207240 [PubMed - as supplied by publisher]
Source: Medicinal Chemistry - Category: Chemistry Authors: Tags: Med Chem Source Type: research
Abstract In the last years, several cases of pediatric epilepsies misdiagnosed and treated as gastrointestinal (GI) disorders have been reported. The aim of this study was to evaluate both frequency and characteristics of these erroneous diagnoses. We identified children who had received a previous misdiagnosis of GI disorder out of 858 consecutive patients with a diagnosis of epilepsy at our hospital from 2010 to 2015. Misdiagnosis was observed in 21 patients (2.4%): 7 children with West syndrome, 10 with temporal lobe epilepsy, and 4 with Panayiotopoulos syndrome. The majority of children with a misdiagnosis (12...
Source: Epilepsy and Behaviour - Category: Neurology Authors: Tags: Epilepsy Behav Source Type: research
Authors: Amano H, Tanaka Y, Kawashima H, Deie K, Suzuki K, Fujiogi M, Morita K, Iwanaka T, Uchida H Abstract Fundoplication is a standard treatment for gastroesophageal reflux disease (GERD) in neurologically impaired children. However, it has a high recurrence rate due to wrap herniation and disruption resulting from the failure or enlargement of the esophageal hiatus suture site. In adult patients with GERD, reinforcement of the sutured esophageal hiatus with a mesh significantly reduces the recurrence rate after surgery for esophageal hiatus hernia. In children, there are no big series of fundoplication with mes...
Source: Nagoya Journal of Medical Science - Category: International Medicine & Public Health Tags: Nagoya J Med Sci Source Type: research
Conclusion We don’t know how many other children were given this experimental vaccine, but Jodie Marchant is the only one known to have survived this and her family is the only family in the world to hold the records proving this vaccine corruption has gone on. In recent times, due to immense pressure regarding informed consent not being provided often enough to parents by doctors, the Supreme Court Montgomery ruling was passed. This ruling will help change the way doctors provide informed consent and should help families receive compensation for their child’s vaccine injury. This ruling might also help the Mar...
Source: - Category: Allergy & Immunology Authors: Tags: Augustina Ursino Case Reports on Vaccine Injury Human Top Stories truth about vaccines Source Type: blogs
Determine whether the four-factor structure of the Medication Adherence Reasons Scale (MAR-Scale) is replicated in additional comorbid conditions.
Source: Value in Health - Category: International Medicine & Public Health Authors: Source Type: research
Angelman syndrome (AS) is a neurogenetic disorder characterized by intellectual disability, expressive speech impairment, movement disorder, epilepsy, and a happy demeanor. Children with AS are frequently reported to be poor feeders during infancy and as having gastrointestinal issues such as constipation, reflux, and abnormal food related behaviors throughout their lifetime. To assess the prevalence of gastrointestinal disorders in individuals with AS, we retrospectively analyzed medical records of 120 individuals seen at the Angelman Syndrome Clinic at Massachusetts General Hospital and 43 individuals seen at the Univers...
Source: American Journal of Medical Genetics Part A - Category: Genetics & Stem Cells Authors: Tags: ORIGINAL ARTICLE Source Type: research
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