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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BACKGROUND: Regular infant carrying might be a contributing factor for the development and progression of low back and pelvic girdle pain in mothers after childbirth. However, the neuromechanical adaptations of the spine due to different sling-based carryi...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Infants and Children Source Type: news
Publication date: Available online 22 October 2018Source: The SurgeonAuthor(s): Fatih Kucukdurmaz, Mohamed Sukeik, Javad ParviziAbstractBackgroundProponents of the direct anterior approach (DAA) for THAs suggest earlier recovery with no increased complications whereas opponents suggest higher complication rates.MethodsWe conducted a meta-analysis of randomized controlled trials (RCTs) to compare the outcomes of the DAA versus other surgical approaches in primary THAs.ResultsWe identified 18 RCTs suitable for detailed extraction of the data. The RCTs included a total of 1661 patients with a mean age of 62 years (range 55&nd...
Source: The Surgeon - Category: Surgery Source Type: research
AbstractTo validate a Spanish language translation of the ASAS Heath-Index (ASAS-HI) testing, its reliability, construct validity, and responsiveness in Colombian patients with spondyloarthritis. Translation was done following a forward-backward procedure. Patients fulfilling the Assessment of Spondyloarthritis international Society (ASAS) criteria for either axial or peripheral spondyloarthritis (SpA) participated. Test-retest reliability was assessed by intra-class correlation coefficient (ICC) in patients without treatment changes. In patients who required a therapeutic intervention, responsiveness was assessed using th...
Source: Clinical Rheumatology - Category: Rheumatology Source Type: research
AbstractAvailable studies reported contradictory results about serum levels Dickkopf-1 (DKK1), an inhibitor of Wnt signaling in patients with ankylosing spondylitis (AS). In previous studies, we observed in other conditions that parathyroid hormone (PTH) serum levels were an important determinant of DKK1 serum levels. The aim of the present study was to investigate it in patients with AS. We recruited 71 patients diagnosed with AS. Levels of C-reactive protein (CRP), DKK1, PTH, 25OH-vitamin D, and bone turnover markers (intact N-propeptide of type I collagen, P1NP, and C-terminal telopeptide of type I collagen, CTX) were m...
Source: Clinical Rheumatology - Category: Rheumatology Source Type: research
This study included 50 PsA patients and 50 healthy controls with mean ages of 45.02 (SD 12.81) and 45.12 (SD 10.56), respectively. Demographic data of both groups were similar. Concerning the b alance tests, there were significant differences (p 
Source: Rheumatology International - Category: Rheumatology Source Type: research
The objective of the study was to compare the effects of shockwave therapy and laser therapy on pain, neck functionality, and quality of life in patients with myofascial pain syndrome of the trapezius. 61 patients (>  18 years) were randomly allocated to two treatment groups: (1) 31 patients received soft laser therapy once daily in a 3-week period for a total of 15 sessions, (2) 30 patients received shockwave therapy once in a week for 3 weeks, totalling 3 treatments. Resting pain and pain tolerance were as sessed by a 100 mm visual analogue scale; functional status and quality of life were measur...
Source: Rheumatology International - Category: Rheumatology Source Type: research
AbstractComplex Regional Pain Syndrome type 1 (CRPS-1) is a disabling painful disease whose hallmark is pain disproportionate to inciting event. CRPS is also characterized by symptoms and signs, such as vasomotor, sudomotor, trophic and motor changes. Therapeutic approach of CRPS-1 still remains a challenge for clinicians treating a disease with potential heavy consequences on patient prognosis. In the past years, the treatment with bisphosphonates (BPs) has gained some success as confirmed by the results of a number of meta-analyses. The aim of this paper is to point out the pivotal role of bone in CRPS pathogenesis. The ...
Source: Rheumatology International - Category: Rheumatology Source Type: research
AbstractIn patients with a pediatric rheumatic disease (PRD), chronic musculoskeletal pain (CMP) can have a major impact on functioning and social participation. Because CMP is not always alleviated solely by the use of pharmacological approaches, the aim was to systematically review the available evidence regarding non-pharmacological treatment options for reducing CMP in patients with PRD. PubMed, Embase, PsycINFO, and the Cochrane Library were systematically searched for (non-)randomized trials investigating non-pharmacological treatments for CMP in PRD published through October 25, 2017. The GRADE approach was used to ...
Source: Rheumatology International - Category: Rheumatology Source Type: research
AbstractOsteoarthritis (OA) is a chronic disorder associated mainly with pain, limited range of motion, stiffness, low-grade systemic inflammation, and articular cartilage destruction. Recent studies have demonstrated the involvement of chondrocyte differentiation (hypertrophy) as one of the mechanisms in cartilage degradation in OA. This implicates the involvement of principal changes in the regulation of cellular function associated with profound alterations in chondrocyte energy metabolism in the course of cartilage resorption. Therefore, this review describes the major energy-generating pathways and their regulatory mo...
Source: Rheumatology International - Category: Rheumatology Source Type: research
Rebecca Lane, now 39, from Sherborne, Dorset, weighed 18st 5lbs (116.5kg) when she was diagnosed in July 2016. She was forced to have her uterus and cervix removed.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
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