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Medtech approvals: FDA releases November 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015: Summary of PMA Originals &Supplements Approved Originals: 3 Supplements: 69 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 30 Total On Hold: 27 Summary of PMA Supplements Under Review Total Under Review: 583 Total Active: 433 Total On Hold: 150 Summary of All PMA Submissions Originals: 4 Supplements: 75 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 69 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 193.4 FDA Time: 103.0 Days MFR Time: 90.4 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P130018 11/24/15 ProACT™ Adjustable Continence Therapy for Men Uromedica, Inc. Plymouth, MN 55441 Approval for the ProACT Adjustable Continence Therapy for Men. This device is indicated for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy. P130028 11/20/15 Algovita Spinal Cord Stimulation System Algostim, LLC Blaine, MN 55449 Approval for the Algovita Spinal Cord Stimulation System. This device is indicated as an aid in the management ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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Authors: Sawicka-Żukowska M, Krawczuk-Rybak M, Bernatowicz P, Muszyńska-Rosłan K, Konstantynowicz J, Łuczyński W Abstract The study objective was to assess the prevalence of cardiovascular disease risk factors in patients treated for childhood cancer (N = 101) and to determine the involvement of clinical (cancer type and therapy) and/or genetic (FTO gene rs9939609 polymorphism) factors. Anthropometric features, laboratory findings, and standardized osteodensitometric indices (fat and lean mass) were considered. Overweight/obesity was found in 17.82% of the patients; however, central adiposity was found in as m...
Source: International Journal of Endocrinology - Category: Endocrinology Tags: Int J Endocrinol Source Type: research
Conclusion: The eIF2α polymorphism is associated with islet β-cell function in a Chinese population. PMID: 29675042 [PubMed]
Source: International Journal of Endocrinology - Category: Endocrinology Tags: Int J Endocrinol Source Type: research
A THERAPY that could make lung cancer treatable is “one of the biggest breakthroughs in cancer in years”. It combines two drugs and “decloaks” the cancer, revealing it to the body’s immune system that in turn attacks it.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Authors: Farronato D, Fumagalli D, Asa'ad F, Rasperini G Abstract The aim of this study was to evaluate different cleaning procedures for customized laser-microtextured titanium abutments. A total of 20 customized laser-microtextured abutments were randomized into four groups: no cleaning (control group), ultrasonic treatments + autoclave cycle (group 1), ultrasonic treatments + argon plasma (group 2), and only argon plasma (group 3). Surface contaminants were assessed through scanning electron microscopy and energy-dispersive x-ray spectroscopy microanalysis. In the control group, 99.96% of the abutment surfaces w...
Source: International Journal of Periodontics and Restorative Dentistry - Category: Dentistry Tags: Int J Periodontics Restorative Dent Source Type: research
This study evaluated the impact of soft tissue grafts to reduce marginal peri-implant recession (MPR) after 1 year of follow-up. A total of 24 patients with one single failing maxillary incisor presenting facial bone dehiscence and receiving an immediate implant, bone graft, and provisional were randomly divided into three groups (n = 8 in each group): control (CTL), collagen matrix (CM), and connective tissue graft (CTG). Clinical, photographic, and tomographic analyses were performed to evaluate tissue alterations. The use of a CTG avoided MPR (P
Source: International Journal of Periodontics and Restorative Dentistry - Category: Dentistry Tags: Int J Periodontics Restorative Dent Source Type: research
Authors: Ng P, Hu X, Wan S, Mo H, Deng F Abstract Bicortical dental implantation technique was regarded as an alternative to internal sinus lift technique with bone grafting in dental implantation in atrophic maxillae. The purpose of this retrospective study was to evaluate the survival rates and bone stability of 6- and 10-mm implants in the posterior maxilla using bicortical dental implantation techniques after 1 to 5 years of prosthetic loading. A total of 53 patients received posterior maxillary implant treatments. Of these, 31 patients received bicortical dental implantation (group A), and 25 patients received...
Source: International Journal of Periodontics and Restorative Dentistry - Category: Dentistry Tags: Int J Periodontics Restorative Dent Source Type: research
Authors: Schierano G, Vercellotti T, Modica F, Corrias G, Russo C, Cavagnetto D, Baldi D, Romano F, Carosa S Abstract This retrospective study evaluated implant survival rate (SR) and marginal bone loss around dental implants placed with ultrasonic implant site preparation. A total of 156 implants were placed in 28 totally and partially edentulous patients. Bone loss was measured on intraoral paralleling digital radiographs taken at the impression phase and after 4 years of loading. As 3 implants (1.92%) failed at the second surgery stage, the SR was 98.08% after 4 years. The mean marginal bone loss was 0.52 &plusm...
Source: International Journal of Periodontics and Restorative Dentistry - Category: Dentistry Tags: Int J Periodontics Restorative Dent Source Type: research
Conclusion. Evidence from the meta-analysis suggested that JPBS combined with chemotherapy has a positive effect on gastric cancer treatment. However, additional rigorously designed and large sample randomized controlled trials are required to confirm the efficacy and safety of this treatment. PMID: 29675052 [PubMed]
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Authors: Alemu A, Tamiru W, Nedi T, Shibeshi W Abstract Background: Pain and inflammation are the major health problems commonly treated with traditional remedies mainly using medicinal plants. Leonotis ocymifolia is one of such medicinal plants used in folkloric medicine of Ethiopia. However, the plant has not been scientifically evaluated. The aim of this study was to evaluate analgesic and anti-inflammatory effects of the 80% methanol leaves extract of Leonotis ocymifolia using rodent models. Method: The central and peripheral analgesic effect of the extract at 100, 200, and 400 mg/kg dose levels was ...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Authors: Cai Y, Wang Y, Zhi F, Xing QC, Chen YZ Abstract Treating type 2 diabetes mellitus (T2DM) using thiazolidinediones and biguanides can present several challenges for patients. Sanggua Drink (SGD) is a commonly used agent in traditional Chinese medicine, and it consists of Folium Mori, Fructus Momordicae Charantiae, Radix Puerariae Lobatae, and Rhizoma Dioscorea. The hypoglycemic effects and mechanisms of SGD extracts on insulin resistance in diabetic rats were investigated. SGD (1.24 g/kg orally) was verified in T2DM rats induced by a high-fat diet and streptozotocin. The results showed that SGD treat...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
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