Medtech approvals: FDA releases June 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015: Summary of PMA Originals &Supplements Approved Originals: 5 Supplements: 80 Summary of PMA Originals Under Review Total Under Review: 53 Total Active: 22 Total On Hold: 31 Summary of PMA Supplements Under Review Total Under Review: 575 Total Active: 418 Total On Hold: 157 Summary of All PMA Submissions Originals: 4 Supplements: 72 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 80 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 115.2 FDA Time: 97.1 Days MFR Time: 18.1 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P120024 6/11/15 activL® Artificial Disc Aesculap Implant Systems, LLC Center Valley, PA 18034 Approval for the activL® Artificial Disc. This device is indicated for reconstruction of the disc at one level (L4-L5 or L5- S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL® Artificial Disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL® Arti...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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ConclusionsFindings suggest that self-harm behavior and psychiatric disorders are associated with increased ED utilization for subsequent chronic disease-related ED utilization. Chronic disease among adolescent psychiatric patients should be attended to, potentially involving new models of clinical follow-up care.
Source: Journal of Adolescence - Category: Child Development Source Type: research
Conclusion: Immunization with the quadrivalent vaccine (HPV6, HPV11, HPV16, and HPV18) could potentially prevent genital warts caused by HPV infection.Intervirology
Source: Intervirology - Category: Virology Source Type: research
Source: Journal of Pain and Symptom Management - Category: Palliative Care Source Type: research
Source: Journal of Pain and Symptom Management - Category: Palliative Care Source Type: research
CONCLUSIONS: Ectopic leiomyoma are a late and rare complication of a laparoscopic hysterectomy with power morcellation of the uterus. PMID: 30892129 [PubMed - as supplied by publisher]
Source: Acta Chirurgica Belgica - Category: Surgery Tags: Acta Chir Belg Source Type: research
Authors: Lee CW, Sung SH, Huang WM, Tsai YL, Chen HY, Hsu CP, Shih CC, Chung KP Abstract BACKGROUND AND OBJECTIVES: Age is a traditional risk factor for open-heart surgery. The efficacy and safety of transcatheter edge-to-edge mitral valve repair, using MitraClip (Abbott Vascular), has been demonstrated in patients with severe mitral regurgitation (MR). Since octogenarians or older patients are usually deferred to receive open-heart surgery, the main interest of this study is to elucidate the procedural safety and long-term clinical impact of MitraClip in elderly patients. METHODS: Patients with symptomatic sev...
Source: Korean Circulation Journal - Category: Cardiology Tags: Korean Circ J Source Type: research
Background and Purpose: A growing population of older adults will require health care professionals to become increasingly knowledgeable in geriatric care. Patient ratings, functional measures, and emphasis on health and wellness should be part of geriatric physical therapy practice. The purpose of the current study was to examine relationships between self-rated health (SRH) and movement-related variables in older adults using the International Classification of Functioning, Disability, and Health (ICF) as a research framework. Associations between body mass index (BMI), gait, and balance confidence were also explored. ...
Source: Journal of Geriatric Physical Therapy - Category: Physiotherapy Tags: Research Reports Source Type: research
Conclusions: Ambulatory PACE participants have average levels of physical function that are dangerously close to thresholds thought to indicate vulnerability for further disability development, hospitalization, and nursing home admission. Both dementia and comorbidity burden are associated with declines in physical function, and the interaction between these risk factors is a telling indicator to functional decline in higher-level ambulatory tasks. PACE program clinicians can use this information to better identify participants at risk for limited physical function. Further research should investigate consequences of fun...
Source: Journal of Geriatric Physical Therapy - Category: Physiotherapy Tags: Research Reports Source Type: research
In this study, to estimate the states that are not directly available from the Bergman minimal model a high-order sliding mode observer is proposed. Then fractional calculus is combined with sliding mode control (SMC) for blood glucose regulation to create more robustness performance and make more degree of freedom and flexibility for the proposed method. Then an adaptive fractional-order SMC is proposed. The adaptive SMC protect controller against disturbance and uncertainties while the fractional calculus provides robust performance. Numerical simulation verifies that the proposed controllers have better performance in t...
Source: IET Systems Biology - Category: Biology Source Type: research
This paper deals with the design of robust observer based output feedback control law for the stabilisation of an uncertain nonlinear system and subsequently apply the developed method for the regulation of plasma glucose concentration in Type 1 diabetes (T1D) patients. The principal objective behind the proposed design is to deal with the issues of intra-patient parametric variation and non-availability of all state variables for measurement. The proposed control technique for the T1D patient model is based on the attractive ellipsoid method (AEM). The observer and controller conditions are obtained in terms of linear mat...
Source: IET Systems Biology - Category: Biology Source Type: research
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