Humanitarian Device Exemption

Known as: Humanitarian Device Exemptions, Exemption, Humanitarian Device, Device Exemptions, Humanitarian 
A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals… (More)
National Institutes of Health

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Compassionate Use TrialsStructured Product Labeling Marketing Category Terminology

Papers overview

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2011
2011
Misuse of the FDA's humanitarian device exemption in deep brain stimulation for obsessive-compulsive disorder.
Deep brain stimulation-a novel surgical procedure-is emerging as a treatment of last resort for people diagnosed with… (More)
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Highly Cited
2009
Highly Cited
2009
Non-smooth / non-convex economic dispatch by a novel hybrid differential evolution algorithm
This paper presents a novel stochastic optimisation approach to determining the feasible optimal solution of the economic… (More)
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2007
2007
Quantification of cerebral blood flow and oxygen metabolism with 3-dimensional PET and 15O: validation by comparison with 2-dimensional PET.
UNLABELLED Quantitative PET with (15)O provides absolute values for cerebral blood flow (CBF), cerebral blood volume (CBV… (More)
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Highly Cited
2005
Highly Cited
2005
Evolutionary optimization with data collocation for reverse engineering of biological networks
MOTIVATION Modern experimental biology is moving away from analyses of single elements to whole-organism measurements. Such… (More)
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Highly Cited
2005
Highly Cited
2005
Variable scaling hybrid differential evolution for solving network reconfiguration of distribution systems
This paper presents an effective method-variable scaling hybrid differential evolution (VSHDE)-for solving the network… (More)
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2005
2005
Evaluation of the CD14/-260 polymorphism and house dust endotoxin exposure in the Barbados Asthma Genetics Study.
BACKGROUND Both a functional promoter polymorphism in the gene encoding CD14 (C-260T) and exposure to endotoxin are believed to… (More)
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Highly Cited
2004
Highly Cited
2004
Ant direction hybrid differential evolution for solving large capacitor placement problems
This paper presents an ant direction hybrid differential evolution (ADHDE) with integer programming which is effective and… (More)
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Highly Cited
2002
Highly Cited
2002
A longitudinal analysis of wheezing in young children: the independent effects of early life exposure to house dust endotoxin, allergens, and pets.
BACKGROUND It has been postulated that exposure to bacterial endotoxins and animals early in life might confer protection against… (More)
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Highly Cited
1995
Highly Cited
1995
Comparative pulmonary toxicities and carcinogenicities of chronically inhaled diesel exhaust and carbon black in F344 rats.
Diesel exhaust (DE) is a known pulmonary carcinogen in rats, and the carcinogenic response is known to require the presence of… (More)
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Highly Cited
1992
Highly Cited
1992
A randomized clinical trial of high-dose epinephrine and norepinephrine vs standard-dose epinephrine in prehospital cardiac arrest.
OBJECTIVE To determine the relative efficacy of high- vs standard-dose catecholamines in initial treatment of prehospital cardiac… (More)
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