AIMC Topic: Product Surveillance, Postmarketing

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Ontology-based specification and generation of search queries for post-market surveillance.

Journal of biomedical semantics May 30, 2019
BACKGROUND: The vigilant observation of medical devices during post-market surveillance (PMS) for identifying safety-relevant incidents is a non-trivial task. A wide range of sources has to be monitored in order to integrate all accessible data about...
Safety Product Surveillance, Postmarketing Data Mining Equipment and Supplies Biological Ontologies
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The Role of the FDA in Ensuring the Safety and Efficacy of Artificial Intelligence Software and Devices.

Journal of the American College of Radiology : JACR Oct 30, 2018
Product Surveillance, Postmarketing United States United States Food and Drug Administration Device Approval Software Patient Safety Humans Artificial Intelligence
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Classification-by-Analogy: Using Vector Representations of Implicit Relationships to Identify Plausibly Causal Drug/Side-effect Relationships.

AMIA ... Annual Symposium proceedings. AMIA Symposium Feb 10, 2017
An important aspect of post-marketing drug surveillance involves identifying potential side-effects utilizing adverse drug event (ADE) reporting systems and/or Electronic Health Records. These data are noisy, necessitating identified drug/ADE associa...
Drug-Related Side Effects and Adverse Reactions ROC Curve Humans Adverse Drug Reaction Reporting Systems Models, Theoretical Product Surveillance, Postmarketing Machine Learning Support Vector Machine Electronic Health Records
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Classification of nervous system withdrawn and approved drugs with ToxPrint features via machine learning strategies.

Computer methods and programs in biomedicine Feb 9, 2017
BACKGROUND AND OBJECTIVES: Early-phase virtual screening of candidate drug molecules plays a key role in pharmaceutical industry from data mining and machine learning to prevent adverse effects of the drugs. Computational classification methods can d...
Nervous System Ethylamines Safety-Based Drug Withdrawals Drug Approval Support Vector Machine Risk Carbon Linear Models Product Surveillance, Postmarketing Area Under Curve Pattern Recognition, Automated False Positive Reactions Data Mining Toluene Patient Safety Drug Monitoring Computer Simulation Pharmaceutical Preparations Humans Sensitivity and Specificity Algorithms Benzene
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First-in-human robotic percutaneous coronary intervention for unprotected left main stenosis.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions May 18, 2016
The safety and feasibility of robotically-assisted percutaneous coronary intervention (PCI) for simple coronary lesions has been demonstrated. The CorPath robotic system (Corpath 200, Corindus, Waltham, MA) consists of a robotic arm mounted on the ca...
California Radiography, Interventional Therapy, Computer-Assisted Surgical Equipment Humans Angioplasty, Balloon, Coronary Product Surveillance, Postmarketing Intra-Aortic Balloon Pumping Fluoroscopy Prospective Studies Coronary Stenosis Female Coronary Angiography Feasibility Studies Aged Stents Equipment Design Heart-Assist Devices Registries Ventricular Function, Left Aged, 80 and over Treatment Outcome Adult Hemodynamics Robotics Male
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Handling Temporality of Clinical Events for Drug Safety Surveillance.

AMIA ... Annual Symposium proceedings. AMIA Symposium Nov 5, 2015
Using longitudinal data in electronic health records (EHRs) for post-marketing adverse drug event (ADE) detection allows for monitoring patients throughout their medical history. Machine learning methods have been shown to be efficient and effective ...
Electronic Health Records Drug-Related Side Effects and Adverse Reactions Algorithms Product Surveillance, Postmarketing Humans Databases, Factual Machine Learning
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Leveraging Data Pipeline and LLM to Advance Patient Safety Event Studies.

Studies in health technology and informatics May 15, 2025
Research utilizing the open-access MAUDE database frequently reveals unclear methodologies for extracting and processing medical device report (MDR) data, reducing reproducibility and consistency. By harnessing the OpenFDA API and our MAUDE extract-t...
Natural Language Processing Data Mining Programming Languages Product Surveillance, Postmarketing Humans Patient Safety Electronic Health Records
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A machine learning framework to adjust for learning effects in medical device safety evaluation.

Journal of the American Medical Informatics Association : JAMIA Jan 1, 2025
OBJECTIVES: Traditional methods for medical device post-market surveillance often fail to accurately account for operator learning effects, leading to biased assessments of device safety. These methods struggle with non-linearity, complex learning cu...
Decision Trees Equipment and Supplies Product Surveillance, Postmarketing Equipment Safety Humans Machine Learning United States
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Learning to detect and understand drug discontinuation events from clinical narratives.

Journal of the American Medical Informatics Association : JAMIA Oct 1, 2019
OBJECTIVE: Identifying drug discontinuation (DDC) events and understanding their reasons are important for medication management and drug safety surveillance. Structured data resources are often incomplete and lack reason information. In this article...
Support Vector Machine Narration Natural Language Processing Product Surveillance, Postmarketing Drug Therapy Area Under Curve Humans Pharmacovigilance Machine Learning Electronic Health Records
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Learning predictive models of drug side-effect relationships from distributed representations of literature-derived semantic predications.

Journal of the American Medical Informatics Association : JAMIA Oct 1, 2018
OBJECTIVE: The aim of this work is to leverage relational information extracted from biomedical literature using a novel synthesis of unsupervised pretraining, representational composition, and supervised machine learning for drug safety monitoring.
Humans Natural Language Processing Supervised Machine Learning Semantics Product Surveillance, Postmarketing Databases, Bibliographic Drug-Related Side Effects and Adverse Reactions Data Mining Pharmacovigilance
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