US EditionFDA Backs First AI Tool for Use in Trials, Targeting MASH
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7 Articles
FDA Qualifies PathAI’s AIM-MASH as First AI-Powered Pathology Drug Development Tool – RamaOnHealthcare
What You Should Know: – PathAI has secured a historic regulatory milestone with the FDA qualification of its AIM-MASH AI Assist tool, making it the first AI-powered pathology biomarker to receive such status under the FDA’s Drug Development Tool (DDT) program. This follows a similar qualification from the European Medicines Agency (EMA) earlier this year, [...]
The US drug agency, the FDA, has officially recognized AIM-NASH, the first qualified AI model to assist in the development of medicines against liver diseases. This tool, already validated in Europe, analyzes biopsies to standardize and accelerate clinical trials, promising to reduce delays and costs while keeping the pathologist at the centre of the decision.
This is a major breakthrough. The FDA has just approved the very first AI tool designed to accelerate clinical trials for serious liver diseases.
FDA Qualifies First AI-Powered Tool for Use in MASH Clinical Trials
What You Should Know: – PathAI has secured a historic regulatory milestone with the FDA qualification of its AIM-MASH AI Assist tool, making it the first AI-powered pathology biomarker to receive such status under the FDA’s Drug Development Tool (DDT) program. This follows a similar qualification from the European Medicines Agency (EMA) earlier this year, establishing AIM-MASH as the first tool of its kind to hold dual U.S. and EU regulatory re…
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