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.
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.
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.
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.