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Representative image: AI-enabled real-world evidence analysis in a diagnostics laboratory highlights how OM1’s 650,000-patient study supported FDA approval of Hologic’s Aptima HPV Assay for primary cervical cancer screening.
Medical Devices & Diagnostics

Did OM1 just prove AI-powered real-world evidence can survive FDA scrutiny?

FDA-grade evidence is getting bigger and harder to collect. OM1’s Hologic study shows how AI may change medtech submissions.

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Representative image: A clinician uses a portable ultrasound and elastography system for non-invasive liver and spleen assessment, highlighting how E-Scopics’ FDA-cleared Hepatoscope enhancements could support point-of-care liver disease diagnostics and cirrhosis complication monitoring.
Medical Devices & Diagnostics

Why E-Scopics’ new Hepatoscope clearance could reshape point-of-care liver diagnostics

Liver diagnostics need speed and scale. E-Scopics’ Hepatoscope clearance tests whether bedside elastography can move deeper into routine care.

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Pharma & Biotech

Paradigm Health’s FDA collaboration puts clinical trial data automation under the spotlight

FDA review is moving closer to real time. Paradigm Health’s pilot with Amgen and AstraZeneca could reset clinical trial infrastructure.

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Medical Devices & Diagnostics

OpenEvidence expands beyond search as Tandem partnership pushes medical AI into prescription access workflows

OpenEvidence and Tandem are linking clinical AI with prior authorization automation. Read what this could change for prescribing, access, and workflow.

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