Device Approval
Mostrando 1-8 de 8 artigos, teses e dissertações.
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1. Heterotopic Heart Transplantation as a Left Ventricular Biological Assistance: a New Two-Stage Method Proposal
Abstract Since Barnard’s first heterotopic heart transplant in 1974, Copeland’s method has been the greatest contribution to heterotopic transplants but has the drawback of donor’s right ventricular atrophy. This new method proposes a modification in the anastomosis of the superior vena cava aiming to pre-serve donor’s right ventricular function by d
Braz. J. Cardiovasc. Surg.. Publicado em: 2020-12
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2. Behavioral and Electrophysiological Assessment of Adults Who Underwent Cochlear Implantation After Hearing Aid Experience
Abstract Introduction Cochlear implantation has been considered a viable option to restore hearing perception in adults with severe to profound postlingual hearing loss. Objectives To analyze behavioral hearing responses and P300 latency and amplitude measurements in adults with bilateral sensorineural hearing loss at two phases, first when they were usi
Int. Arch. Otorhinolaryngol.. Publicado em: 2020-06
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3. High Risk of COVID-19 Infection for Head and Neck Surgeons
Abstract Introduction Cochlear implantation has been considered a viable option to restore hearing perception in adults with severe to profound postlingual hearing loss. Objectives To analyze behavioral hearing responses and P300 latency and amplitude measurements in adults with bilateral sensorineural hearing loss at two phases, first when they were usi
Int. Arch. Otorhinolaryngol.. Publicado em: 2020-06
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4. Carne única, nueva carne. Cuerpo y democratización de tecnologías biomédicas de transformación corporal para personas trans en el actual escenario argentino
Resumo Este artigo tem como objetivo refletir sobre o processo que vai desde a produção de conhecimento biomédico sobre diversas identidades sexuais genéricas, até mudanças nos modos de representar as pessoas transexuais como sujeitos de direito frente ao governo argentino. A intervenção dos coletivos organizados no cenário político imprimiu uma s�
Physis. Publicado em: 25/02/2019
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5. Perfil de hidrogênio de soluções de cloridrato de dobutamina e citrato de fentanila segundo variação de sistemas de administração intravenosa, temperatura e luminosidade. / Hydrogen profiles of dobutamine hydrochloride and fentanyl citrate solutions according to variations of intravenous administration systems, temperature and luminosity.
Experimental study which analyzed the potential of hydrogen (pH) of dobutamine hydrochloride, fentanyl citrate, dextrose solution (D5W), drug substances D5W and the association of these at D5W, according to a varied systems for intravenous administration, temperature and luminosity over time. The data collected between April and July 2008, in a research labo
Publicado em: 2009
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6. New perspectives on medical devices control in Brazil: vision of the health authorities and of the vendors / Novas perspectivas no controle dos produtos para saúde no Brasil : a visão do setor regulador e do setor regulado
This is a qualitative and prospective study based on interviews performed with the main stakeholders of the healthcare products regulatory control in Brazil. A total of 44 professionals were involved in the survey: 25 were predominantly employees responsible for regulatory affairs or quality assurance areas in medical device vendors, manufacturers or distr
Publicado em: 2006
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7. Lower Cost and Faster Product Approval Through Proper Software Design Controls
Buggy software is to a medical device like kryptonite is to Superman. Through careful verification and validation, device makers can prevent product recalls, reduce time to market, and improve profitability.
BioCommunications LLC.
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8. Formation of a national network for rapid response to device and lead advisories: The Canadian Heart Rhythm Society Device Advisory Committee
The Canadian Heart Rhythm Society (CHRS) Device Advisory Committee was commissioned to respond to advisories regarding cardiac rhythm device and lead performance on behalf of the CHRS. In the event of an advisory, the Chair uses an e-mail network to disseminate advisory information to Committee members broadly representative of the Canadian device community.
Pulsus Group Inc.