AI in Healthcare

The latest on artificial intelligence transforming medicine

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OM1’s Massive Real-World Dataset Could Set a New Standard for FDA Evidence Packages

OM1 says it supported FDA approval of Hologic’s Aptima HPV assay with a real-world submission based on data from 650,000 patients. The scale of the dataset underscores how real-world evidence is shifting from a nice-to-have supplement to a core regulatory asset.

real-world evidenceFDA approvaldiagnosticsHologic

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