FDA cleared AI medical devices list

mdrregulator.com
mdrregulator.com
The US FDA updated the list of AI/ML-Enabled Medical Devices, authorizing 950 devices ⚕️ MDR Regulator
The FDA’s updated list of AI/ML-enabled medical devices, which now includes 950 authorized devices
medtechspectrum.com
medtechspectrum.com
The 2025 Index: 100 FDA-Approved AI-Driven Medical Devices
The U.S. Food and Drug Administration (FDA) has recently authorised over 100 artificial intelligence (...
medtechdive.com
medtechdive.com
5 takeaways from the FDA’s updated list of cleared AI/ML medical devices
The vast majority of AI/ML devices cleared between August 2022 and July 2023 went through the...
healthimaging.com
healthimaging.com
FDA adds dozens of AI-enabled radiology applications to list of clearances
Around two-thirds of all approved artificial intelligence-powered clinical devices are catere...
stanford.edu
stanford.edu
Clinicians can ‘chat’ with medical records through new AI software, ChatEHR
ChatEHR, artificial intelligence software developed at Stanford Medicine, is expediting chart reviews and othe...
dlapiper.com
dlapiper.com
FDA issues Artificial Intelligence-Enabled Device Software Functions draft guidance | DLA Piper
While the guidance does not provide specifics on how these risk analysis programs and documentation or monitor...
thelancet.com
thelancet.com
FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks - The Lancet Digital Health
The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine le...
fda.gov
fda.gov
FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices | FDA
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support de...
pew.org
pew.org
How FDA Regulates Artificial Intelligence in Medical Products
These devices must undergo the full premarket approval process, and developers must submit clinical ev...
nature.com
nature.com
How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations | npj Digital Medicine
We reviewed 1016 FDA authorizations of AI/ML-enabled medical devices to develop a taxonomy ca...
intuitionlabs.ai
intuitionlabs.ai
Top 20 Medtech Companies Leveraging AI in 2025 | IntuitionLabs
A comprehensive analysis of leading medical technology companies worldwide that are at the fo...
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