Medtech approvals: FDA releases December 2015 PMAs

The Food & Drug Administration today released a list of pre-market approvals granted in December 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 81 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 599 Total Active: 423 Total On Hold: 176 Summary of All PMA Submissions Originals: 3 Supplements: 92 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 81 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 163.1 FDA Time: 140.4 Days MFR Time: 22.7 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / IN…

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://ift.tt/1T1fwsA
via IFTTT

from #Med Blogs by Alexandros G.Sfakianakis via Alexandros G.Sfakianakis on Inoreader http://ift.tt/1X6Uo3l
via IFTTT

Neural representation of object-specific attentional priority

Publication date: 1 April 2016
Source:NeuroImage, Volume 129
Author(s): Taosheng Liu
Humans can flexibly select locations, features, or objects in a visual scene for prioritized processing. Although it is relatively straightforward to manipulate location- and feature-based attention, it is difficult to isolate object-based selection. Because objects are always composed of features, studies of object-based selection can often be interpreted as the selection of a combination of locations and features. Here we examined the neural representation of attentional priority in a paradigm that isolated object-based selection. Participants viewed two superimposed gratings that continuously changed their color, orientation, and spatial frequency, such that the gratings traversed the same exact feature values within a trial. Participants were cued at the beginning of each trial to attend to one or the other grating to detect a brief luminance increment, while their brain activity was measured with fMRI. Using multi-voxel pattern analysis, we were able to decode the attended grating in a set of frontoparietal areas, including anterior intraparietal sulcus (IPS), frontal eye field (FEF), and inferior frontal junction (IFJ). Thus, a perceptually varying object can be represented by patterned neural activity in these frontoparietal areas. We suggest that these areas can encode attentional priority for abstract, high-level objects independent of their locations and features.

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://ift.tt/1Sw9Dnp
via IFTTT

from #Med Blogs by Alexandros G.Sfakianakis via Alexandros G.Sfakianakis on Inoreader http://ift.tt/1X6UqrR
via IFTTT

Hippocampus and amygdala volumes from magnetic resonance images in children: Assessing accuracy of FreeSurfer and FSL against manual segmentation

Publication date: 1 April 2016
Source:NeuroImage, Volume 129
Author(s): Dorothee Schoemaker, Claudia Buss, Kevin Head, Curt A. Sandman, Elysia P. Davis, M. Mallar Chakravarty, Serge Gauthier, Jens C. Pruessner
The volumetric quantification of brain structures is of great interest in pediatric populations because it allows the investigation of different factors influencing neurodevelopment. FreeSurfer and FSL both provide frequently used packages for automatic segmentation of brain structures. In this study, we examined the accuracy and consistency of those two automated protocols relative to manual segmentation, commonly considered as the "gold standard" technique, for estimating hippocampus and amygdala volumes in a sample of preadolescent children aged between 6 to 11years. The volumes obtained with FreeSurfer and FSL-FIRST were evaluated and compared with manual segmentations with respect to volume difference, spatial agreement and between- and within-method correlations.Results highlighted a tendency for both automated techniques to overestimate hippocampus and amygdala volumes, in comparison to manual segmentation. This was more pronounced when using FreeSurfer than FSL-FIRST and, for both techniques, the overestimation was more marked for the amygdala than the hippocampus. Pearson correlations support moderate associations between manual tracing and FreeSurfer for hippocampus (right r=0.69, p<0.001; left r=0.77, p<0.001) and amygdala (right r=0.61, p<0.001; left r=0.67, p<0.001) volumes. Correlation coefficients between manual segmentation and FSL-FIRST were statistically significant (right hippocampus r=0.59, p<0.001; left hippocampus r=0.51, p<0.001; right amygdala r=0.35, p<0.001; left amygdala r=0.31, p<0.001) but were significantly weaker, for all investigated structures. When computing intraclass correlation coefficients between manual tracing and automatic segmentation, all comparisons, except for left hippocampus volume estimated with FreeSurfer, failed to reach 0.70. When looking at each method separately, correlations between left and right hemispheric volumes showed strong associations between bilateral hippocampus and bilateral amygdala volumes when assessed using manual segmentation or FreeSurfer. These correlations were significantly weaker when volumes were assessed with FSL-FIRST. Finally, Bland–Altman plots suggest that the difference between manual and automatic segmentation might be influenced by the volume of the structure, because smaller volumes were associated with larger volume differences between techniques.These results demonstrate that, at least in a pediatric population, the agreement between amygdala and hippocampus volumes obtained with automated FSL-FIRST and FreeSurfer protocols and those obtained with manual segmentation is not strong. Visual inspection by an informed individual and, if necessary, manual correction of automated segmentation outputs are important to ensure validity of volumetric results and interpretation of related findings.

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://ift.tt/1QJxInb
via IFTTT

from #Med Blogs by Alexandros G.Sfakianakis via Alexandros G.Sfakianakis on Inoreader http://ift.tt/1SMP5W9
via IFTTT

Widespread metachronous carcinoid tumour metastases to the head and neck: a unique presentation

Publication date: Available online 4 February 2016
Source:British Journal of Oral and Maxillofacial Surgery
Author(s): Mohamed Koraitim, Anne V. Spedding, Katy Bradley, Peter A. Brennan
Carcinoid tumours are usually slow-growing, neuroendocrine neoplasms that primarily affect the gastrointestinal tract and bronchial tree. Although relatively rare, isolated, single metastasis to the head and neck has been reported. We present a unique case of 6 metachronous carcinoid metastases to both parotid glands, the left submandibular gland, upper lip, and thyroid, over 3 years. To our knowledge, this widespread presentation in the head and neck has not previously been reported.

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://ift.tt/1PDRDoE
via IFTTT

from #Med Blogs by Alexandros G.Sfakianakis via Alexandros G.Sfakianakis on Inoreader http://ift.tt/1X6Unw5
via IFTTT

Physiology of haemostasis

Publication date: Available online 4 February 2016
Source:Anaesthesia & Intensive Care Medicine
Author(s): James Sira, Lorna Eyre
Haemostasis is a complex and sophisticated process that requires the interplay of multiple physiological pathways. Cellular and molecular mechanisms interact to seal damaged blood vessels with localized clot formation preventing significant bleeding. Once vascular integrity is restored, clot breakdown occurs and normal haemostasis is reinstated. Thrombohaemorrhagic imbalance may occur in the perioperative period or during critical illness, leading to an increased risk of thrombosis, bleeding or in some instances both. Therefore an understanding of the normal physiological processes is important for the anaesthetist as: (i) it allows us to identify targets for the therapeutic modulation of bleeding and thrombosis; (ii) many commonly encountered medications alter the normal haemostatic pathways and it is important to recognize their effects; and (iii) it enables enhanced understanding of the dynamic tests of haemostasis and clotting.

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://ift.tt/1PXJ9uk
via IFTTT

from #Med Blogs by Alexandros G.Sfakianakis via Alexandros G.Sfakianakis on Inoreader http://ift.tt/1SMP8kH
via IFTTT

The genetic assessment of looked after children: common reasons for referral and recent advances

Looked after children are recognised as generally having greater health needs than their peers. There are numerous potential causes, environmental and genetic, and the aetiology is often multifactorial. Assessments, especially clinical genetic ones, may be limited if the information available is incomplete or not shared. There have been some exciting recent advances in diagnostic genetic testing and more are on the horizon. However, we are currently only able to make a genetic diagnosis in less than half of patients, even when both parents are available for comparative testing. There may, therefore, remain an inevitable degree of residual uncertainty about the genetic contribution to a particular child's problems. There are increasing societal pressures for genetic information to be made available to individuals in general. However, there are significant considerations in carrier/predictive testing in children and we would maintain that looked after children should not be treated differently to other children in this regard, unless there is a compelling 'best interest' justification for so doing. Diagnostic criteria exist for fetal alcohol syndrome and other embryopathies and should be applied. Such should be considered as diagnoses of exclusion, so a child should not be prematurely labelled with these conditions, without fully assessing for the contribution of other factors, genetic or otherwise.

from #Medicine-SfakianakisAlexandros via o.lakala70 on Inoreader http://ift.tt/1X66dqn
via IFTTT

from #Med Blogs by Alexandros G.Sfakianakis via Alexandros G.Sfakianakis on Inoreader http://ift.tt/1VRniTK
via IFTTT

Regulation of Stem Cell Proliferation and Cell Fate Specification by Wingless/Wnt Signaling Gradients Enriched at Adult Intestinal Compartment Boundaries

by Ai Tian, Hassina Benchabane, Zhenghan Wang, Yashi Ahmed

Intestinal stem cell (ISC) self-renewal and proliferation are directed by Wnt/β-catenin signaling in mammals, whereas aberrant Wnt pathway activation in ISCs triggers the development of human colorectal carcinoma. Herein, we have utilized the Drosophila midgut, a powerful model for ISC regulation, to elucidate the mechanisms by which Wingless (Wg)/Wnt regulates intestinal homeostasis and development. We provide evidence that the Wg signaling pathway, activation of which peaks at each of the major compartment boundaries of the adult intestine, has essential functions. Wg pathway activation in the intestinal epithelium is required not only to specify cell fate near compartment boundaries during development, but also to control ISC proliferation within compartments during homeostasis. Further, in contrast with the previous focus on Wg pathway activation within ISCs, we demonstrate that the primary mechanism by which Wg signaling regulates ISC proliferation during homeostasis is non-autonomous. Activation of the Wg pathway in absorptive enterocytes is required to suppress JAK-STAT signaling in neighboring ISCs, and thereby their proliferation. We conclude that Wg signaling gradients have essential roles during homeostasis and development of the adult intestine, non-autonomously controlling stem cell proliferation inside compartments, and autonomously specifying cell fate near compartment boundaries.

from #Medicine-SfakianakisAlexandros via o.lakala70 on Inoreader http://ift.tt/1K12fgZ
via IFTTT

from #Med Blogs by Alexandros G.Sfakianakis via Alexandros G.Sfakianakis on Inoreader http://ift.tt/1PDhBZt
via IFTTT

from #Med Blogs by Alexandros G.Sfakianakis via Alexandros G.Sfakianakis on Inoreader http://ift.tt/1TH2sb7
via IFTTT