Medtech approvals: FDA releases August 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals &Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130.3 Days MFR Time: 98.7 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P140008 8/5/15 Orbera™ Intragastric Balloon Apollo Endosurgery, Inc. Austin, TX 78746 Approval for the Orbera Intragastric Balloon. The ORBERA™ Intragastric Balloon System is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of ≥ 30 and ≤ 40 kg/m2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA™ is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and beha...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

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Publication date: Available online 12 December 2018Source: Journal of the American College of RadiologyAuthor(s): Felix M. Gonzalez, J. Matthew Kerchberger, Douglas D. Robertson, Yara Younan, Adam Singer, Walter A. Carpenter, Richard Duszak, James R. Roberson, Monica B. UmpierrezAbstractPurposeTo evaluate the appropriateness of MRI ordering practices and their effect on clinical management for nontraumatic knee pain at the primary care clinics of a large public urban hospital.Materials and MethodsIn all, 196 consecutive MRIs for nontraumatic knee pain ordered from primary care clinics in a large public urban hospital over ...
Source: Journal of the American College of Radiology - Category: Radiology Source Type: research
In the above referenced article, portions of the text and table reading “CALGB 80801” should have read “CALGB 80101,” to correctly reflect the referenced Fuchs CS et al. publication and CALGB study. The authors regret the error.
Source: International Journal of Radiation Oncology * Biology * Physics - Category: Radiology Tags: Erratum Source Type: research
CONCLUSIONS: The present study suggests that about 8.24% of resident doctors have Problematic internet use/IA. Problematic internet use/IA is associated with presence of higher level of depressive symptoms, perceived stress and burn out. Further, Problematic internet use/IA is also associated with higher likelihood of facing violence in the hands of patients and their caregivers. PMID: 30529568 [PubMed - as supplied by publisher]
Source: Asian Journal of Psychiatry - Category: Psychiatry Tags: Asian J Psychiatr Source Type: research
Authors: Wu Y, Jia K, Wu H, Sang A, Wang L, Shi L, Jiang K, Dong J Abstract Diabetic retinopathy (DR) is a severe microvascular complication of diabetes and the primary cause of vision loss in diabetic patients. Previous research has revealed that long non‑coding RNAs (lncRNAs) and microRNAs (miRNAs) play pivotal roles in the pathogenesis of DR. However, the roles of lncRNA‑miRNA‑mRNA interactions in DR are poorly understood. In the present study, we aimed to compute a global triple network of competitive endogenous RNAs (ceRNAs) in order to pinpoint essential molecules. We found that there were 802 ...
Source: Molecular Medicine Reports - Category: Molecular Biology Tags: Mol Med Rep Source Type: research
Melatonin attenuates renal fibrosis in diabetic mice by activating the AMPK/PGC1α signaling pathway and rescuing mitochondrial function. Mol Med Rep. 2018 Nov 29;: Authors: Li J, Li N, Yan S, Lu Y, Miao X, Gu Z, Shao Y Abstract Mitochondrial homeostasis is a highly regulated process that serves a critical role in the maintenance of renal structure and function. The growing interest in the field of mitochondrial homeostasis promises to provide more information regarding the mechanisms involved in diabetic renal fibrosis, and aid in the development of novel strategies to combat the disease. In the ...
Source: Molecular Medicine Reports - Category: Molecular Biology Tags: Mol Med Rep Source Type: research
Authors: Zhang C, Yu W, Huang C, Ding Q, Liang C, Wang L, Hou Z, Zhang Z Abstract High‑mobility group box chromosomal protein (HMGB‑1) contributes to osteoarthritis (OA) by modulating various oxidative, inflammatory and apoptotic signaling pathways. The effect of chrysin (CH), a natural plant flavonoid, and its functional interaction with HMGB‑1, was investigated in a chondrocyte model of OA. Human chondrocytes were pre‑treated with CH, and then subsequently treated with IL‑1β to induce the formation of chondrocytes similar to those found in OA joints. Next, the expression level of HMGB‑1 was deter...
Source: Molecular Medicine Reports - Category: Molecular Biology Tags: Mol Med Rep Source Type: research
Role of the mTOR‑FOXO1 pathway in obesity‑associated renal tubulointerstitial inflammation. Mol Med Rep. 2018 Dec 05;: Authors: Sun H, Shao X, He J, Golos M, Shi B Abstract Since obesity is largely responsible for the growing incidence of renal tubulointerstitial inflammation, exploration into the mechanisms of obesity‑associated tubulointerstitial inflammation is essential. Studies have demonstrated that mammalian target of rapamycin (mTOR) is a crucial molecule in the pathogenesis of renal inflammation, including regulating the expression of inflammatory factors. The purpose of the present...
Source: Molecular Medicine Reports - Category: Molecular Biology Tags: Mol Med Rep Source Type: research
Intranasal erythropoietin ameliorates neurological function impairments and neural pathology in mice with chronic alcoholism by regulating autophagy‑related Nrf2 degradation. Mol Med Rep. 2018 Nov 29;: Authors: Nie X, Wang W, Wang Q, Zhu D, Song H Abstract The neurological disorders and neural pathology brought about by chronic alcoholism are difficult to be reversed. Increasing evidence highlights the protective roles of erythropoietin (EPO) in neurodegenerative diseases and injuries of the central nervous system. In the present study, we investigated the therapeutic effects of EPO on the neurologic...
Source: Molecular Medicine Reports - Category: Molecular Biology Tags: Mol Med Rep Source Type: research
Medial epicondylitis and lateral epicondylitis are among the most common elbow pathologies affecting people aged between 40 and 50 years. Although epicondylitis is often a self-limiting condition that improves with conservative treatment, the condition can be difficult to eradicate. The purpose of this study was to compare the effectiveness of platelet-rich plasma (PRP) injections and ultrasound-guided percutaneous tenotomy (Tenex) for the treatment of medial or lateral epicondylitis. Our hypothesis was that the Tenex procedure would not be inferior to PRP injections in the treatment of medial or lateral epicondylitis.
Source: Journal of Shoulder and Elbow Surgery - Category: Orthopaedics Authors: Source Type: research
We thank the authors for the comments related to this article. We appreciate their comments and suggestions and agree that these studies can be challenging but can also move patient care forward. Obtaining accurate pain scores can be highly subjective and relies on patients reporting pain at a single point in time and a nurse recording the pain score accurately.7 Although pain is subjective, our ability to enter and access the data is much less subjective. In our institution, we have a highly integrated electronic medical records system through EPIC Enterprises (Verona, WI, USA).
Source: Journal of Shoulder and Elbow Surgery - Category: Orthopaedics Authors: Source Type: research
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