FDA to launch ICD registry, update GUDID system

The FDA is slated to launch a new national registry of implantable cardiac defibrillators, according to a report from the Regulatory Affairs Professionals Society. The move comes after some reluctance from industry players around the use of unique device identifiers, according to the report. The FDA implemented a final rule in 2013 requiring UDIs on most medical devices, including updated labeling designs and requiring that certain information be submitted to the federal watchdog’s publicly available Global Unique Device Identification Database, RAPS reports. The implementation of a national UDI system helps provide structure to improve best practices, including in care and delivery of medical devices and is especially important for high-risk implantable devices such as ICDs, according to the report. The national registry of ICDs aren’t the only national registry the FDA will be launching this year, RAPS reports, as FDA Center for Devices and Radiological Health head Jeffrey Shuren announced in 2015 that the group was looking to build a National Breast Implant Registry as well. The registry is slated to launch later this year, with the American Society of Plastic Surgeons aiding in the effort. The FDA is also looking to update its GUDID system based on feedback and program needs early next month, according to the reports. Updates include making data in premarket submissions and supplement numbers publicly available. “The premarket numbers provide an essentia...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiac Implants Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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Publication date: Available online 8 December 2018Source: Journal of Sound and VibrationAuthor(s): Andrè M.N. Spillere, Julio A. CordioliAbstractAcoustic liners are widely employed in turbofan aero-engines as acoustic treatment. Their performance is determined by its acoustic impedance in the presence of flow. In recent years, much effort has been devoted to find the “optimum impedance” i.e. the impedance that results in the maximum attenuation. Although such analysis can be carried out by means of numerical simulations, analytical expressions can also be derived in order to predict the optimum impedance...
Source: Journal of Sound and Vibration - Category: Physics Source Type: research
Publication date: Available online 8 December 2018Source: Journal of Sound and VibrationAuthor(s): Xiaoling Jin, Huang Xu, Yong Wang, Zhilong HuangAbstractAs a mechanical system is placed on a belt moving with a constant speed, the friction between the mass block and the belt induces the stick-slip vibration. If the mechanical system is imposed by random external excitations at the same time, it will suffer from more complex random stick-slip vibration which is quite difficult to predict analytically. This manuscript tries to establish an approximately analytical procedure to evaluate the response statistics of the random ...
Source: Journal of Sound and Vibration - Category: Physics Source Type: research
CONCLUSION: These new guidelines should help to harmonize clinical practice and limit exposure to antibiotics. LEVEL OF EVIDENCE: 4. PMID: 30501940 [PubMed - as supplied by publisher]
Source: Progres en Urologie - Category: Urology & Nephrology Tags: Prog Urol Source Type: research
Authors: Ortiz A, Sanchez-Niño MD, Crespo-Barrio M, De-Sequera-Ortiz P, Fernández-Giráldez E, García-Maset R, Macía-Heras M, Pérez-Fontán M, Rodríguez-Portillo M, Salgueira-Lazo M, Sánchez-Álvarez E, Santamaría-Olmo R, Simal-Blanco F, Pino-Pino MD Abstract The Global Burden of Disease (GBD) study measures the health of populations worldwide and by country on an annual basis and aims at helping guide public policy on health issues. The GBD estimates for Spain in 2016 and recent trends in mortality and morbidity from 2006 to 2016 were recent...
Source: Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia - Category: Urology & Nephrology Tags: Nefrologia Source Type: research
Authors: Rodríguez-Sánchez E, Navarro-García JA, Aceves-Ripoll J, Álvarez-Llamas G, Segura J, Barderas MG, Ruilope LM, Ruiz-Hurtado G Abstract BACKGROUND AND OBJECTIVE: Matrix metalloproteinases (MMPs) are involved in deleterious tissue remodeling associated with target organ damage in renal disease. The aim of this study was to study the association between renal dysfunction and activity of the inflammatory metalloproteinase MMP-9 in hypertensive patients with mild-moderate chronic kidney disease (CKD). MATERIAL AND METHODS: Plasmatic active MMP-9, total MMP-9, tissue inhibitor of M...
Source: Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia - Category: Urology & Nephrology Tags: Nefrologia Source Type: research
BED BUG bites causes irritation. If you have an infestation of bed bugs your are likely to be bitten. How do you spot the bites? How to get rid of bed bugs. Pictures of bites.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Publication date: Available online 8 December 2018Source: Biocatalysis and Agricultural BiotechnologyAuthor(s): Kandasamy Kathiresan, Rajendran Narendran, Kaliyamoorthy Kalidasan, Palanisamy DineshAbstractIn this paper, we analyzed the growth performance of 3 year old Rhizophora mucronata in response to pruning of shoot branches in the lower trunk, on 70, 117, 180 and 292 days of the experiment corresponding to four seasons (Post monsoon, summer, Pre monsoon and monsoon). The growth increased with number of shoot branch pruned, and days of growth. The pruning exercise exhibited significant promontory effect on the leaf exp...
Source: Biocatalysis and Agricultural Biotechnology - Category: Biotechnology Source Type: research
DEMENTIA symptoms can affect people in different ways, particular because there are different forms of the disease. Vascular dementia is one of the most common types of dementia, but memory loss, which often associated with dementia, isn ’t usually the main early symptom.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Italian police are questioning more witnesses to find who sprayed an irritant, triggering a deadly disco stampede
Source: ABC News: Health - Category: Consumer Health News Tags: Health Source Type: news
Publication date: Available online 8 December 2018Source: Journal of Molecular StructureAuthor(s): C. Jellali, N. Dridi, N. Maaroufi, F. Kwabia Tchana, Xavier Landsheere, H. ArouiAbstractUsing Fourier transform spectrometer, He-broadening coefficients have been measured for the first time in the P and R branches of the 2ν1 parallel band of carbonyl sulfide (OCS). The measurements have been performed at room temperature for rotational quantum number up to J = 70. A total of 131 lines were measured using a nonlinear least squares multi-pressure spectrum fitting procedure. Since the measurements have been performed usi...
Source: Journal of Molecular Structure - Category: Molecular Biology Source Type: research
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