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Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices
… cott-gottlieb-md-steps-toward-new-tailored-review-framework-artificial … Artificial intelligence and machine learning have the … in personalized medicine. The ability of artificial intelligence and machine learning software to learn from …
Artificial Intelligence at FDA: Publications
… ience-research/artificial-intelligence-and-medical-products/artificial-intelligence-fda-publications … AI has the potential to … constituent updates from the Agency. More Publications on Artificial Intelligence Document Type Guidance Document Rule …
FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience
… lability/fdas-istand-pilot-program-accepts-submission-first-artificial-intelligence-based-and-digital-health … [1/23/2024] FDA's … (ISTAND) Pilot Program . This submission is the first artificial intelligence-based and digital health …
Focus Area: Artificial Intelligence
… e-research/focus-areas-regulatory-science-report/focus-area-artificial-intelligence … Importance to FDA Artificial intelligence (AI) solutions have the potential to …
Artificial Intelligence
… /about-fda/nctr-research-focus-areas/artificial-intelligence … An FDA Artificial Intelligence (AI) Program for Toxicology Weida …
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
… events/press-announcements/fda-permits-marketing-artificial-intelligence-based-device-detect-certain-diabetes-related-eye … permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye …
Artificial Intelligence/Machine Learning Assisted Image Analysis for Characterizing Biotherapeutics
… proteins, one possible solution is the application of artificial intelligence/machine learning approach (AI/ML), specifically, … advance drug product quality? Application of artificial intelligence/machine learning (AI/ML) in the form of CNNs has …
Harnessing the Potential of Artificial Intelligence
… /news-events/fda-voices/harnessing-potential-artificial-intelligence … By: Robert M. Califf, M.D., Commissioner of … for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and also to harness its …
Artificial Intelligence Program: Research on AI/ML-Based Medical Devices
… ulatory-science-research-programs-conducted-osel/artificial-intelligence-program-research-aiml-based-medical-devices … The Artificial Intelligence (AI) Program in the FDA’s Center for Devices and …
FDA Releases Artificial Intelligence/Machine Learning Action Plan
… /news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan … Today, … Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a …
FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing
… /fda-releases-two-discussion-papers-spur-conversation-about-artificial-intelligence-and-machine … By: Patrizia Cavazzoni, M.D., … Director of the Center for Drug Evaluation and Research Artificial intelligence (AI) and machine learning (ML) are no …
FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures
… designed to detect wrist fractures in adult patients. “Artificial intelligence algorithms have tremendous potential to help … detection and diagnostic software that uses an artificial intelligence algorithm to analyze two-dimensional …
Application of Artificial Intelligence and Machine Learning for Precision Medicine - 02/17/2023
… /drugs/news-events-human-drugs/application-artificial-intelligence-and-machine-learning-precision-medicine-02172023 … a one-day virtual public workshop entitled “Application of Artificial Intelligence and Machine Learning for Precision Medicine” on …
Information Visualization Platform (InfoViP): CDER’s New Artificial Intelligence Safety Surveillance Tool
… ations/information-visualization-platform-infovip-cders-new-artificial-intelligence-safety-surveillance … The FDA’s Center for Drug … Visualization Platform (InfoViP). InfoViP incorporates artificial intelligence (AI) and advanced visualizations to …
Import Screening Pilot Unleashes the Power of Data and Leverages Artificial Intelligence
… s/import-screening-pilot-unleashes-power-data-and-leverages-artificial-intelligence … By: Stephen M. Hahn, M.D., Commissioner of … work the agency is undertaking to leverage our use of artificial intelligence (AI) as part of the FDA’s New Era of …
TechTalk Podcast Episode 3: Artificial Intelligence in the New Era of Smarter Food Safety
… ter-food-safety-techtalk-podcast/techtalk-podcast-episode-3-artificial-intelligence-new-era-smarter-food-safety … TechTalk Podcast … podcast series on technology and food safety focuses on artificial intelligence (AI) and its potential to advance …
Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER
… … Artificial Intelligence is a machine-based system that can, for a given … or decisions influencing real or virtual environments. Artificial intelligence systems use machine- and human-based inputs to …
FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing - 09/26/2023
… /drugs/fdapqri-workshop-regulatory-framework-utilization-artificial-intelligence-pharmaceutical … About Workshop: FDA and PQRI … on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing on …
FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer
… ss-announcements/fda-authorizes-marketing-first-device-uses-artificial-intelligence-help-detect-potential-signs-colon … Today, the … marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to …
The FDA Moves into Third Phase of Artificial Intelligence Imported Seafood Pilot Program
… /food/cfsan-constituent-updates/fda-moves-third-phase-artificial-intelligence-imported-seafood-pilot-program … Constituent … Drug Administration has kicked off the third phase of the Artificial Intelligence (AI) Imported Seafood Pilot program, …
High Throughput Truthing (HTT) of Pathologist Annotations as a Reference Standard for Validating Artificial Intelligence in Digital Pathology
… g-htt-pathologist-annotations-reference-standard-validating-artificial … Office of the Commissioner … Scientific Poster … Artificial intelligence (AI) in digital pathology can potentially …
Artificial Intelligence and Medical Products
… /science-research/science-and-research-special-topics/artificial-intelligence-and-medical-products … What is Artificial Intelligence? Artificial Intelligence (AI) is a …
Artificial Intelligence and Machine Learning in Software as a Medical Device
… /medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device … Update: March 15, 2024 Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and …
FDA’s Third TechTalk Podcast Will Be on Artificial Intelligence
… san-constituent-updates/fdas-third-techtalk-podcast-will-be-artificial-intelligence … What's New March 21, 2022 Listen to Episode 3 … of the New Era of Smarter Food Safety TechTalk podcast on artificial intelligence. Original Constituent Update March …
Artificial Intelligence and Machine Learning (AI/ML) for Drug Development
… nce-research/science-and-research-special-topics/artificial-intelligence-and-machine-learning-aiml-drug-development … What is Artificial Intelligence and Machine Learning? Artificial Intelligence …