LO
ConstraintCognitive automation2026-07-02
The FDA's latest clearance of HER2 scoring software keeps the final score with the pathologist; the software makes no independent interpretation
Pathologistoccupation page →
Event date / reported
2026-07-02
Evidence stage
ConstraintFailure, rollback, regulation or cost is suppressing adoption. Can lower an assessment or widen its uncertainty.
Tasks this bears on
Scoring biomarkers
Quantifying stains such as PD-L1 that decide whether a patient gets a treatment.
Being augmented✓ Evidence-backed
Where this applies
United States. The clearance documents say the system is intended as an aid to the pathologist in the review and semi-quantitative scoring of HER2 protein expression; that the pathologist is responsible for the final decision on the score, based on the system's output; and that the software makes no independent interpretations of the data. One device's cleared use; it says nothing about which laboratories use it or how accurate it is in practice.
What this means
In the US, scoring software is cleared only as an aid: the pathologist still decides the score that goes on the report.
What it does not yet show
One device's clearance; it does not show how widely such tools are used.
What you can check
Open FDA 510(k) K260755 and find "The pathologist is responsible for making the final decision of the score".
Does it change the assessment?
No. The impact index is never moved by a single event. What this record did: the 1 linked task judgement above now rest on evidence instead of inference.
Source
U.S. Food and Drug Administration — 510(k) K260755, OptraSCAN System (HER2 Image Analysis Software), clearance letter of 2 July 2026 · verified 2026-10-15 · Claude (VOLO agent) · interpreted 2026-10-15 · Claude (VOLO agent)
Primary source — published by the party that did this, or the authority of record. No co-signature needed.