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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Publication date: Available online 20 August 2018Source: Materials Chemistry and PhysicsAuthor(s): Reza Aghaei, Akbar Eshaghi, Abbas Ali AghaeiAbstractIn this work, hollow SiO2-SiO2 nanocomposite thin film was deposited on a glass substrate by a sol-gel dip-coating method. Transmission electron microscopy (TEM), field emission scanning electron microscopy (FE-SEM) and atomic force microscopy (AFM) were used to investigate the structure and morphology of the nanoparticles and films. Surface wettability and optical properties of the thin films were studied by means of water contact angle analyzer and UV-vis spectrophotometer...
Source: Materials Chemistry and Physics - Category: Materials Science Source Type: research
Publication date: Available online 20 August 2018Source: Biocybernetics and Biomedical EngineeringAuthor(s): R. Sumathi, M. Venkatesuslu, Sridhar P. Arjunan
Source: Biocybernetics and Biomedical Engineering - Category: Biomedical Engineering Source Type: research
Publication date: Available online 20 August 2018Source: NeurocomputingAuthor(s): Junjie Zhang, Yong Xia, Haoyue Zeng, Yanning ZhangAbstractDetection of pulmonary nodules on chest CT is an essential step in the early diagnosis of lung cancer, which is critical for best patient care. In this paper, we propose an automated pulmonary nodule detection algorithm, denoted by NODULe, which jointly uses a conventional method for nodule detection and a deep learning model for genuine nodule identification. Specifically, we first use multi-scale Laplacian of Gaussian (LoG) filters and prior shape and size constraints to detect nodul...
Source: Neurocomputing - Category: Neuroscience Source Type: research
ConclusionLow PNI predicts poor survival in LC patients.
Source: Clinica Chimica Acta - Category: Laboratory Medicine Source Type: research
CONCLUSION: We identified a changing pattern of human visceral leishmaniasis occurrence in Ara çatuba: the first period (1999-2009) showed a cyclic pattern, clusters, and presence of spatial dependence in the case point distribution; the second period (2010-2015) showed the lowest rates of all historical series, stable incidence, and cases with a random distribution pattern.
Source: Revista da Sociedade Brasileira de Medicina Tropical - Category: Tropical Medicine Source Type: research
CONCLUSIONS: This study shows that IHC with the tested antiserum increases the sensitivity of the diagnosis and may be recommended for routine use in EMB analyses of cardiac transplant patients with Chagas disease.
Source: Revista da Sociedade Brasileira de Medicina Tropical - Category: Tropical Medicine Source Type: research
Conclusions: Burning pain relief might predict long-term results for the therapeutic use of MCS in CPSP. The substantia gelatinosa may play an important role in the modulation of pain relief mediated by MCS.Stereotact Funct Neurosurg
Source: Stereotactic and Functional Neurosurgery - Category: Neurosurgery Source Type: research
Publication date: Available online 20 August 2018Source: Food HydrocolloidsAuthor(s): Lei Zhong, Ning Ma, Yiliang Wu, Liyan Zhao, Gaoxing Ma, Fei Pei, Qiuhui HuAbstractOat protein isolate is nutritious but with poor processing functionality. Pleurotus ostreatus β-glucan with good processing functionality can be conjugated with oat protein isolate via Maillard reaction, leading to an improved utilization of protein in food industry. Therefore, we produced conjugate with oat protein isolate and Pleurotus ostreatus β-glucan via Maillard reaction under controlled dry-heating conditions. The formation of conjugates wi...
Source: Food Hydrocolloids - Category: Food Science Source Type: research
Publication date: Available online 20 August 2018Source: Food ControlAuthor(s): Jin-Rong Bai, Kai Zhong, Yan-Ping Wu, Grosu Elena, Hong GaoAbstractThe aim of this study was to evaluate the inhibitory activity of shikimic acid (SA) against biofilm formation of Staphylococcus aureus and to explore its potential molecular mechanism. Crystal violet staining assay showed that SA clearly reduced the biomass of the biofilm at its sub-MICs. Light microscopic images and scanning electron microscope (SEM) observations suggested that SA inhibited the biofilm adhesion on glass slides and induced apparent collapse of biofilm architectu...
Source: Food Control - Category: Food Science Source Type: research
This study would help improve whole grain ting processing, which might increase the consumption of this potentially health promoting food.
Source: Food Bioscience - Category: Food Science Source Type: research
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