medtechdive4d
AI in medtech is taking off. Here are 4 trends to watch in 2025.
New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...
JD Supra2d
Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...
FDA ‘stuck to its corner’ with AI draft guidance, leaving plenty of questions unanswered
The first draft guidance provides an initial framework for how the agency will assess AI models in drug development, but the ...
The National Law Review5d
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...
GlobalData on MSN6d
CergenX wins FDA breakthrough designation for neonatal EEG assessment tool
Trained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...
vator20d
The FDA outlines draft guidance on AI for medical devices
AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at ...
Modern Healthcare6d
AI in healthcare needs human oversight. Can hospitals keep up?
Despite the AI hype, the systems require consistent monitoring and staffing to put in place and maintain. The process can be ...
SiliconRepublic6d
CergenX making Waves with new FDA designation
Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...
Seeking Alpha20d
FDA issues first draft guidance on use of AI in drug, medical device development
Also, the FDA advises sponsors to begin discussions with the agency early on about the use of AI credibility assessment or of AI in drug development. The FDA said the guidance was developed based ...