- Essays··9 min read
The Second Read That Happens Before You Press Send
A study published in Radiology found that general radiologists using an AI-driven workflow matched subspecialist cancer detection rates across nearly 578,000 scans. The result is real, but detection rate is not throughput, and the staffing crisis driving 2.5% annual attrition in radiology remains unmeasured. The clinical win and the capacity win require different budgets; the trial answered only one.
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The PCCP Constraint
The Predetermined Change Control Plan is FDA's mechanism for letting AI-enabled medical devices update without a new submission. It is not a solution to the adaptive-AI problem. It is a scoping exercise written in advance. The modifications a vendor can ship without re-filing are precisely and only those the engineer defined eighteen months before knowing what the field would ask for.
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