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Dec 5, 2024 | 
mondaq.com | Nathan Brown |Marlee Gallant
Today FDA issued final guidance to provide recommendations for
predetermined change control plans (PCCPs) tailored to artificial
intelligence (AI) enabled device software functions. FDA recognizes
that development of AI-enabled devices is an iterative process, and
PCCPs are intended to allow developers to plan for modifications,
while continuing to provide a reasonable assurance of safety and
effectiveness.
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Dec 5, 2024 | 
jdsupra.com | Nathan Brown |Marlee Gallant
December 5, 2024
To embed, copy and paste the code into your website or blog:
Today FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions.
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Dec 4, 2024 | 
akingump.com | Nathan Brown |Marlee Gallant
By: Nathan A. Brown, Marlee P. GallantToday FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions. FDA recognizes that development of AI-enabled devices is an iterative process, and PCCPs are intended to allow developers to plan for modifications, while continuing to provide a reasonable assurance of safety and effectiveness.
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Nov 27, 2024 | 
mondaq.com | Anna K. Abram |Marlee Gallant
AdvaMed, the world's largest medical technology association
representing device, diagnostics and digital technology companies,
released a white paper that reviews the current landscape
of artificial intelligence (AI)-based applications and products in
the health care sector, and identifies steps to accelerate the use
of AI in medical technologies.
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Nov 26, 2024 | 
mondaq.com | Nathan Brown |Marlee Gallant
Researchers from the National Institutes of Health (NIH) have developed
an algorithm that harnesses AI to help accelerate the process
of matching potential volunteers for relevant clinical research
trials. The algorithm, called TrialGPT, is intended to help
clinicians navigate the vast range of clinical trials available to
patients by identifying potential matches and providing a summary
of how that person meets the criteria for study enrollment.
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Nov 26, 2024 | 
jdsupra.com | Marlee Gallant
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based applications and products in the health care sector, and identifies steps to accelerate the use of AI in medical technologies.
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Nov 25, 2024 | 
akingump.com | Anna K. Abram |Marlee Gallant
By: Anna K. Abram, Marlee P. GallantAdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based applications and products in the health care sector, and identifies steps to accelerate the use of AI in medical technologies.
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Nov 12, 2024 | 
mondaq.com | Nathan Brown |Marlee Gallant
FDA and the Department of Veterans Affairs (VA) announced last week that they plan to develop
the first intergovernmental health artificial intelligence (AI)
lab. This lab would test health-related AI applications for safety
and effectiveness in a virtual lab environment. VA Undersecretary
for Health Dr. Shereef Elnahal announced the news during the
Veterans Health Administration Innovation Experience conference. The VA serves 9 million veterans—the largest health system in
the country.
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Nov 11, 2024 | 
jdsupra.com | Nathan Brown |Marlee Gallant
FDA and the Department of Veterans Affairs (VA) announced last week that they plan to develop the first intergovernmental health artificial intelligence (AI) lab. This lab would test health-related AI applications for safety and effectiveness in a virtual lab environment. VA Undersecretary for Health Dr. Shereef Elnahal announced the news during the Veterans Health Administration Innovation Experience conference. The VA serves 9 million veterans—the largest health system in the country.
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Nov 8, 2024 | 
akingump.com | Nathan Brown |Marlee Gallant
By: Nathan A. Brown, Marlee P. GallantFDA and the Department of Veterans Affairs (VA) announced last week that they plan to develop the first intergovernmental health artificial intelligence (AI) lab. This lab would test health-related AI applications for safety and effectiveness in a virtual lab environment. VA Undersecretary for Health Dr. Shereef Elnahal announced the news during the Veterans Health Administration Innovation Experience conference.
