3 of 1,357 Cleared AI Devices Have Public Outcome Trials. The Study Has No Non-AI Comparator.
The census counts publicly registered evidence, so it measures disclosure. Without a non-AI comparator it cannot show this is an AI problem.
Diagnostics
A Jury Convicted the Philips Engineer. The Approach Came as His Plant Was Closing.
The approach came in 2017 as Philips prepared to close the plant. A site closure is a knowledge event before it is a cost event.
ASCO’s First ctDNA Guideline Found Few Instances of Clinical Utility. Residual Disease Got No Recommendation at All.
Most of the guideline concerns where ctDNA should not be used. The application carrying the largest commercial expectations got no recommendation.
Roche Cleared an Alzheimer’s Blood Test With Three Result Categories. The Middle One Is Where PET Survives.
A three-way result means some patients resolve neither way, and those still go to imaging. Roche has not said how many land in the middle.
FDA Moved a Class of Cancer Tests From PMA to 510(k). Fewer Than Five Parties Commented.
The order moves these tests from PMA to 510(k). One special control was deleted, and the predicate chain is where the change compounds.
A KAIST Barrier Chip Separated Three Glioblastoma Patients That MGMT Testing Called Identical
Three glioblastoma patients returned identical MGMT results and behaved differently on a barrier chip. The sample size is three, and the framing still matters.
Freenome’s Lung Test Is Indicated for People Who Never Show Up
Freenome defined its population by the failure of the existing pathway, not by anything measurable in the patient. That is the decision worth reading.
Korea Cleared Two Diagnostics on One Day, and Both Remove a Specialist
Nobody gained insurance access. Designation is the gate before the negotiation. The real story is that both lead technologies remove a specialist.
Teledyne Put Its Antitrust Argument in the Press Release, Product by Product
Mehrabian spent a paragraph itemising exactly how the two businesses do not overlap. Executives do that when a competition authority is reading.
The Alzheimer’s Blood Test Just Moved Into the GP’s Office, Which Is the Whole Point
GPs in North West London are running C2N’s Alzheimer’s blood test before referral, testing whether accurate amyloid detection works in primary care.