AI in Healthcare

The latest on artificial intelligence transforming medicine

News stories discovered and organized by an automated pipeline. Covering clinical deployments, research breakthroughs, regulation, and industry developments.

Filtered by: HPVClear filter
regulationBriefGlance

AI powers FDA nod for Hologic HPV test in a landmark real-world study

A real-world study helped power FDA approval for Hologic’s HPV assay, according to a new report. The case is another sign that AI-assisted evidence generation is becoming central to regulatory success in diagnostics.

FDAHPVreal-world studydiagnostics
clinical

OM1’s 650,000-Patient Real-World Submission Shows Evidence Generation Is Becoming an AI Problem Too

OM1 supported a regulatory submission for Hologic’s Aptima HPV assay using real-world data from 650,000 patients, highlighting the scale now required to make a persuasive evidence case. The submission reflects a growing trend in which data infrastructure and analytics are becoming central to regulatory strategy.

Business Wire
real-world evidencediagnosticsFDA submission

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