Results 1 to 10 of about 315,340 (245)
Deep Brain Stimulation for Obsessive-Compulsive Disorder: Real World Experience Post-FDA-Humanitarian Use Device Approval [PDF]
Frontiers in Psychiatry, 2021 Background: While case series have established the efficacy of deep brain stimulation (DBS) in treating obsessive-compulsive disorder (OCD), it has been our experience that few OCD patients present without comorbidities that affect outcomes associated ...
Lora Kahn +6 more
doaj +2 more sources
Drugs, Devices, and the FDA: Part 2
JACC: Basic to Translational Science, 2016 As with new drugs, the U.S. Food and Drug Administration’s approval process is intended to provide consumers with assurance that, once it reaches the market place, a medical device is safe and effective in its intended use.
Gail A. Van Norman, MD
doaj +3 more sources
Key Information Influencing Patient Decision-Making About AI in Health Care: Survey Experiment Study [PDF]
Journal of Medical Internet ResearchBackgroundArtificial intelligence (AI)–enabled devices are increasingly used in health care. However, there has been limited research on patients’ informational preferences, including which elements of AI device labeling enhance patient understanding ...
Xuan Zhu +7 more
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Review of approvals and recalls of US specific medical devices in general and plastic surgery
Surgery in Practice and Science, 2023 Background: Medical devices in the United States can be FDA approved either by the premarket notification (510(k)) or premarket approval process (PMA). Applications for PMA are more intensive than 510(k).
Aashka Shah +2 more
doaj +1 more source
Development of New Endovascular Devices for Aneurysm Treatment [PDF]
Journal of Stroke, 2018 Since the first use of the Guglielmi detachable coil system for cerebral aneurysm embolization in 1990, various endovascular methods have been developed to treat large numbers of aneurysms.
Zhen Yu Jia +8 more
doaj +1 more source
International Journal of Endocrinology, 2021 Objective. The objective of this article is to provide a high-profile review and discussion on the study design and statistical analysis of pivotal clinical trials conducted to demonstrate the safety and effectiveness of closed-loop investigational ...
Sravya B. Shankara +5 more
doaj +1 more source
Postmarketing Trials and Pediatric Device Approvals [PDF]
Pediatrics, 2014 BACKGROUND: Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development.
Hwang, Thomas +2 more
openaire +5 more sources
Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan
Frontiers in Medicine, 2022 Recently, there has been a growing trend in clinical development to utilize real-world data (RWD) to improve the efficiency of drug/medical device development.
Hideki Maeda +2 more
doaj +1 more source
JACC: Basic to Translational Science, 2016 The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible.
Gail A. Van Norman, MD
doaj +1 more source
Current Directions in Biomedical Engineering, 2022 The development of novel and innovative biomaterials and biomedical devices like medical implants is a sophisticated task that requires expertise ranging from physicians over engineers and natural scientists to regulatory officers for clinical ...
Doll Katharina +3 more
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