The FDA Created an AI Office. Now Comes the Hard Part.
CDER's new Office of Innovation and Clinical Trial Modernization fuses AI and RWE policy under one roof. That structural...
FDA Real-World Evidence
The EPoS II Trial Just Made the 3-Year Colonoscopy Standard Look Like a Reflex, Not a Rule
EPoS II RCT finds 5-year colonoscopy surveillance noninferior to 3-year for high-risk adenoma patients, forcing a rethink of global...
Benchmark Scores Don’t Save Patients: Why Clinical AI Needs RCT-Grade Evidence Before It Touches a Workflow
Med-Gemini scores 91% on MedQA. OpenAI's o1-preview hits 96%. Neither number tells you what happens when the algorithm meets...
Proteomic Aging Clocks Just Changed What a Phase 2a Trial Has to Prove
A Nature Biotechnology phase 2a trial ran six proteomic aging clocks simultaneously, here's what that means for biomarker strategy...
The Algorithm Passed Every Benchmark. The Patients Didn’t Notice.
A landmark Nature Medicine RCT found AI improved clinician decisions but not patient outcomes, exposing the fatal flaw in...
Nature Medicine’s 38,753-Patient HF Synthesis Signals a Replicable Model for RWE-Driven Label Expansion Without New RCTs
A 38,753-patient cross-trial synthesis in Nature Medicine maps short-term safety of HF combination therapies—signaling how sponsors can use pooled...
Dubai’s rWGS Scale-Up Rewrites the Diagnostic Playbook — But the Data Infrastructure Problem Stays Unsolved
Dubai Health's rapid whole-genome sequencing rollout for critically ill children delivers diagnostic yields that dwarf standard testing, but exposes...
The Oregon Dataset Is Larger Than the Entire History of Psychedelic Trials. So Why Are Regulators Still Looking the Other Way?
OHSU's 2,363-person Oregon psilocybin dataset dwarfs every RCT in the field's history. Here's what it tells us that clinical...
Rapid Whole-Genome Sequencing Is Leaving the Research Ward and Entering the PICU Protocol — What Sponsors Need to Watch
Nature Medicine's citywide Dubai rWGS study and Seattle Children's 1,000-patient rollout signal a regulatory inflection point for genomic diagnostics...
FDA Has Authorized 1,500 AI Medical Devices. The Evidence for Most of Them Is Still Catching Up.
Over 1,500 AI-enabled medical devices have FDA authorization, yet rigorous RCT validation trails far behind. Here's the mechanism breaking...