AIMC Topic: United States Food and Drug Administration
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Implications of An Evolving Regulatory Landscape on the Development of AI and ML in Medicine.
Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing
Jan 1, 2025
The rapid advancement of artificial intelligence and machine learning (AI/ML) technologies in healthcare presents significant opportunities for enhancing patient care through innovative diagnostic tools, monitoring systems, and personalized treatment...
Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety.
Journal of the American Medical Informatics Association : JAMIA
Jun 20, 2024
OBJECTIVES: Surface the urgent dilemma that healthcare delivery organizations (HDOs) face navigating the US Food and Drug Administration (FDA) final guidance on the use of clinical decision support (CDS) software.
Characterisation of digital therapeutic clinical trials: a systematic review with natural language processing.
The Lancet. Digital health
Mar 1, 2024
Digital therapeutics (DTx) are a somewhat novel class of US Food and Drug Administration-regulated software that help patients prevent, manage, or treat disease. Here, we use natural language processing to characterise registered DTx clinical trials ...
FDA Review of Radiologic AI Algorithms: Process and Challenges.
Radiology
Jan 1, 2024
A Food and Drug Administration (FDA)-cleared artificial intelligence (AI) algorithm misdiagnosed a finding as an intracranial hemorrhage in a patient, who was finally diagnosed with an ischemic stroke. This scenario highlights a notable failure mode ...
New FDA Advisory Team to Focus on AI, Other Digital Health Technologies.
JAMA
Nov 21, 2023
FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks.
The Lancet. Digital health
Sep 1, 2023
The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices through the 510(k) pathway. This pathway allows clearance if the device is substantially equivalent to ...
FDA Approves Artificial Intelligence Device for Guiding Regional Anesthesia.
JAMA
Dec 6, 2022
Biological activities of drug inactive ingredients.
Briefings in bioinformatics
Sep 20, 2022
In a drug formulation (DFM), the major components by mass are not Active Pharmaceutical Ingredient (API) but rather Drug Inactive Ingredients (DIGs). DIGs can reach much higher concentrations than that achieved by API, which raises great concerns abo...
Trial Approach for Biomedical Products: A Regulatory Perspective.
Combinatorial chemistry & high throughput screening
Jan 1, 2022
The modern pharmaceutical industry is transitioning from traditional methods to advanced technologies like artificial intelligence. In the current scenario, continuous efforts are being made to incorporate computational modeling and simulation in dru...
When Medical Devices Have a Mind of Their Own: The Challenges of Regulating Artificial Intelligence.
American journal of law & medicine
Dec 1, 2021
How can an agency like the U.S. Food & Drug Administration ("FDA") effectively regulate software that is constantly learning and adapting to real-world data? Continuously learning algorithms pose significant public health risks if a medical device ca...
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