FDA sets March dates for microbiology, neurology device panel meetings

The FDA this week set two new March dates for public medical device advisory committee meetings, the first to discuss microbiology devices and the second to discuss a specific neurological device, according to official FDA releases. In the microbiology devices panel meeting, slated to be held March 8, a committee of microbiology device experts will discuss and make recommendations regarding novel or alternative approaches to clinical studies and devices intended to detect Human Papillomavirus nucleic acid, according to the release. “These approaches will take into consideration scientific data generated since the approval of the first High Risk HPV screening device in 2003 as well as the effects of HPV vaccination on clinical studies of devices for HPV detection,” the FDA wrote in its posting. Topics slated to be discussed include clinical study design and comparator methods, as well as potential changes to the HR HPV device indications for use considering “continually evolving cervical cancer screening guidelines,” according to the release. During its neurological devices panel, slated to be held March 21, a committee will explore the FDA de novo application for Israel-based Neuronix’s NeuroAD Therapy System, according to the FDA release. The system is intended to provide concurrent neurostimulation and cognitive training to treat mild to moderate Alzheimer’s dementia. The company is currently engaged in a multi-site clinical study of the ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Diagnostics Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance neuronix Source Type: news

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We describe the pattern of potentially targetable genomic alterations in non-ACC salivary gland malignancies according to their frequency rather than to the single non-ACC histotype Expert Opinion/Commentary: The genetic profiling through in-depth molecular analyses [e.g. Next-generation sequencing (NGS)] is advised in all patients affected by recurrent and/or metastatic non-ACC SGCs to find any potentially druggable target. Some histotypes may carry driving mutations (e.g. salivary duct carcinoma and AR expression) that must be investigated and defined. For the rare cancers, access to a referral center is recommended to o...
Source: Expert Opinion on Investigational Drugs - Category: Drugs & Pharmacology Tags: Expert Opin Investig Drugs Source Type: research
The objective of this study was to investigate the association of MTHFR 677C>T (rs1801133), MTR 2756A>G (rs1805087), RFC1 80A>G (rs1051266) and CßS 844ins(68) (no rs#) polymorphisms and thyroid cancer development. The association of these polymorphisms with demographic risk factors and clinical histopathological parameters was also evaluated. Material and methods: The study is a case-control analysis with a total of 462 individuals (151 patients and 311 controls). Polymerase chain reaction-restriction fragment length polymorphism technique was used for genotyping. The χ2 and multiple logistic regress...
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
Authors: Gu LP, Jin S, Xu RC, Zhang J, Geng YC, Shao XY, Qin LB Abstract Introduction: Ovarian cancer (OC) is one of the most common malignancies and the leading cause of cancer-related death among women. The long non-coding RNA Prostate cancer-associated transcript-1 (PCAT-1) has been reported to play important roles in multiple human cancers. However, the role of PCAT-1 in OC has never been investigated. The purpose of this study was to investigate the expression and roles of PCAT-1 in OC. Material and methods: Expression of PCAT-1 and miR-129-5p in OC tissues and cell lines was determined by qRT-PCR. Cell pr...
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
Authors: Zhao B, Zhang J, Chen X, Xu H, Huang B Abstract Introduction: Gastric cancer is one of the most common cancers of the digestive system and is associated with high morbidity and mortality. The aim of this study was to investigate whether miR-26b is involved in the proliferation and resistance to paclitaxel chemotherapy in gastric cancer cells. Material and methods: The expression of miR-26b in gastric cancer cell lines was determined by quantitative real-time PCR. Bioinformatics software was used to predict potential target genes of miR-26b. Luciferase assay was used to verify the interactions between t...
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
Authors: Matyja M, Pasternak A, Szura M, Wysocki M, Pędziwiatr M, Rembiasz K Abstract Introduction: Colonoscopy has been widely regarded as the gold standard in colorectal cancer (CRC) screening. Within recent years different endoscopic imaging techniques have been introduced to improve the quality of colonoscopy. The adenoma detection rate (ADR) is the single most important quality indicator for colonoscopy. The aim of this study was to evaluate the quality of CRC screening expressed by ADR in two different eras of endoscopic technology advancement. Material and methods: We conducted a dual-center study that ...
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
Authors: Wierzba W, Śliwczynski A, Karnafel W, Dziemidok P, Pinkas J Abstract Introduction: Many epidemiological studies show a correlation between the risk of cancer and type 2 diabetes mellitus in various populations. Material and methods: The material was obtained from the database of the National Health Fund. This publication presents a comparison of the incidence of new malignancies in rural and urban populations of diabetic patients in Poland based on the database of the National Health Fund for the period between 1.05.2008 and 30.09.2014. Results: Comparison of the mean incidence of selected maligna...
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
Authors: Hao JQ, Zhang QK, Zhou YX, Chen LH, Wu PF Abstract Introduction: The aim of this meta-analysis was to summarize the evidence on the serum/plasma leptin concentrations in breast cancer (BC) patients, as well as the associations between leptin G-2548A gene polymorphisms and susceptibility to BC. Material and methods: Potentially relevant studies about serum/plasma leptin levels and leptin G-2548A gene polymorphism were selected using the electronic databases PubMed, EMBASE and The Cochrane Library (from January 1 1995 to Jun 30 2017, no language restrictions). The potential sources of heterogeneity were ...
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
In this study, we isolated a virulent strain of DTMUV (SDS) from sparrows near a duck farm and attenuated it via serially passaging (alternately for 100 passages) in specific pathogen-free chicken and duck embryos. We attenuated the virus after the 60th passage (SDS-60), based on the production of embryos that were free of visible lesions and still alive. The 70th adapted strain (SDS-70), obtained with a virus titer of 10−2.46 EID50 was chosen to be the live attenuated vaccine. After immunizing ducklings with the SDS-70 strain, they obtained 100% protection against infection by the SDS-10 virulent strain. Our data de...
Source: Veterinary Microbiology - Category: Veterinary Research Source Type: research
CONCLUSION: Diagnosing parapharyngeal abscess and mediastinitis can be challenging, but should be suspected and ruled out in cases of post-operative odynophagia, fever, and/or neck swelling and thoracic pain. Diagnosis is made based on magnetic resonance imaging and computed tomography findings. Prompt broad-spectrum intravenous antibiotic treatment and surgical drainage should be initiated. Other severe complications such as meningitis should also be considered. PMID: 30898186 [PubMed - in process]
Source: Journal of Laryngology and Otology - Category: ENT & OMF Tags: J Laryngol Otol Source Type: research
ConclusionIn this review, we summarize the potential of omics derived salivary biomarkers as diagnostic and prognostic tools in oral cancer detection and the future clinical benefits associated with these markers.Graphical abstract
Source: Journal of Oral Biosciences - Category: Biomedical Science Source Type: research
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