Medtech approvals: FDA releases September 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in September 2015: Summary of PMA Originals &Supplements Approved Originals: 4 Supplements: 53 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 31 Total On Hold: 24 Summary of PMA Supplements Under Review Total Under Review: 611 Total Active: 461 Total On Hold: 150 Summary of All PMA Submissions Originals: 3 Supplements: 84 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 53 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 127.6 FDA Time: 90.9 Days MFR Time: 36.9 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P100006 9/1/15 Augment® Bone Graft Biomimetic Therapeutics, LLC Franklin, TN 37067 Approval for Augment® Bone Graft. This device is indicated for use as an alternative to autograft in arthrodesis (i.e., surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination), due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients with preoperative or intraoperative evidence indicating the need for supplemental graft material. P1400...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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Publication date: Available online 23 March 2019Source: NeuroImageAuthor(s): Sharmili Edwin Thanarajah, Sandra Iglesias, Bojana Kuzmanovic, Lionel Rigoux, Klaas E. Stephan, Jens C. Brüning, Marc TittgemeyerAbstractInsulin modulates dopamine neuron activity in midbrain and affects processes underlying food intake behaviour, including impulsivity and reward processing. Here, we used intranasal administration and task-free functional MRI in humans to assess time- and dose-dependent effects of insulin on functional connectivity of the dopaminergic midbrain – and how these effects varied depending on systemic insulin...
Source: NeuroImage - Category: Neuroscience Source Type: research
Publication date: Available online 23 March 2019Source: The Annals of Thoracic SurgeryAuthor(s): Amr A. Arafat., Mohammad A. Torky., Mustafa Elhamshary., Mohamed Aboelnasr.AbstractThymic IgG4 is a rare entity that can mimic anterior mediastinal tumors. Preoperative diagnosis is essential to prevent unnecessary surgery. Little is known about disease presentation, diagnosis and response to therapy. A 40-year-old male presented with retrosternal chest pain. X-ray showed anterior mediastinal mass. Intraoperatively, the dense adhesions to the phrenic nerve, aorta and pulmonary artery deemed the tumor unresectable. Thymic IgG4 d...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Publication date: Available online 23 March 2019Source: Trends in Food Science &TechnologyAuthor(s): Katarzyna SamborskaAbstractBackgroundHoney powder is an attractive substitute for liquid honey, which application in food and pharmaceutical industry is limited due to high density and viscosity. However, the manufacturing of powdered honey is still a challenge both for industry as well as researchers. It results from the chemical composition of this unique product, mainly from high content of sugars and organic acids. Honey powder preparation involves the application of appropriate carrier, drying aid and/or enriching ...
Source: Trends in Food Science and Technology - Category: Food Science Source Type: research
Publication date: Available online 23 March 2019Source: Journal of Food Composition and AnalysisAuthor(s): Katsunari Ippoushi, Yoshimi Tanaka, Manabu Wakagi, Naoto Hashimoto, Yuko Takano-IshikawaAbstractPru p 1 and Pru p 3 are proteins found in peach (Prunus persica (L.) Batsch), and they are members of the pathogenesis-related protein 10 (PR-10) and non-specific lipid transfer protein (nsLTP) families, respectively. They are the main allergens of peach. In this paper, we describe a quantitative method for these proteins based on protein absolute quantification with liquid chromatography–tandem mass spectrometry, and...
Source: Journal of Food Composition and Analysis - Category: Food Science Source Type: research
CONCLUSIONS: Polypharmacy is significantly associated with delirium only in surgical units, raising the issue of the relevance of medication review in different clinical settings. Specific drug classes are associated with delirium depending on the clinical setting and dementia diagnosis, suggesting the need to further explore this relationship. PMID: 30901165 [PubMed - in process]
Source: Journal of Clinical Psychiatry - Category: Psychiatry Tags: J Clin Psychiatry Source Type: research
CONCLUSIONS: The large, sustained improvements in weight and diabetes observed in this self-selected sample of surgically treated participants are consistent with results of multiple randomized trials. PMID: 30900413 [PubMed - in process]
Source: Obesity - Category: Eating Disorders & Weight Management Authors: Tags: Obesity (Silver Spring) Source Type: research
Abstract OBJECTIVE: The aim of this study was to test associations of prepregnancy BMI, gestational weight gain, oral glucose challenge test results, and postpartum weight loss as predictors of breast milk leptin, insulin, and adiponectin concentrations and whether these relationships vary over time. METHODS: Milk was collected at 1 and 3 months from 135 exclusively breastfeeding women from the longitudinal Mothers and Infants Linked for Healthy Growth (MILk) study. Hormones were assayed in skimmed samples using ELISA. Mixed-effects linear regression models were employed to assess main effects and effect...
Source: Obesity - Category: Eating Disorders & Weight Management Authors: Tags: Obesity (Silver Spring) Source Type: research
CONCLUSIONS: PAT+Lifestyle decreases weight gain during pregnancy through 12 months post partum in SED African American women with overweight or obesity at the start of pregnancy with minimal additional cost. PMID: 30900408 [PubMed - in process]
Source: Obesity - Category: Eating Disorders & Weight Management Authors: Tags: Obesity (Silver Spring) Source Type: research
Authors: PMID: 30900407 [PubMed - in process]
Source: Obesity - Category: Eating Disorders & Weight Management Tags: Obesity (Silver Spring) Source Type: research
Publication date: Available online 23 March 2019Source: Redox BiologyAuthor(s): Ersilia Varone, Diego Pozzer, Simona Di Modica, Alexander Chernorudskiy, Leonardo Nogara, Martina Baraldo, Mario Cinquanta, Stefano Fumagalli, Rocio Nur Villar-Quiles, Maria-Grazia De Simoni, Bert Blaauw, Ana Ferreiro, Ester ZitoAbstractSelenoprotein N (SELENON) is an endoplasmic reticulum (ER) protein whose loss of function leads to congenital myopathies associated with insulin resistance (SEPN1-related myopathies). The exact cause of the insulin resistance in patients with SELENON loss of function is not known. Skeletal muscle is the main con...
Source: Redox Biology - Category: Biology Source Type: research
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