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
How does medical device regulation perform in the United States and the European union? A systematic review. [PDF]
PLoS Medicine, 2012 BackgroundPolicymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems.
Daniel B Kramer +2 more
doaj +5 more sources
Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies [PDF]
JMIR AIThe adaptive nature of artificial intelligence (AI), with its ability to improve performance through continuous learning, offers substantial benefits across various sectors.
Eduardo Carvalho +10 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
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
doaj +2 more sources
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
Pain detection with bioimpedance methodology from 3-dimensional exploration of nociception in a postoperative observational trial [PDF]
, 2020 Although the measurement of dielectric properties of the skin is a long-known tool for assessing the changes caused by nociception, the frequency modulated response has not been considered yet.
Copot, Dana +4 more
core +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
Prevalence of Postpartum Family Planning Service Coverage in Selected Referral Facilities of Nepal [PDF]
, 2020 Introduction: Nepal Society of Obstetricians and Gynecologists jointly with the Nepalese government and with the support from the International Federation of Obstetrics and Gynecology has implemented an initiative to institutionalize postpartum family ...
Acharya, S +15 more
core +1 more source