LO
ConstraintCognitive automation2021-09-21
AI for prostate biopsies was authorised only as an adjunct whose output should not be used as the primary diagnosis, the US FDA decided in 2021
Pathologistoccupation page →
Event date / reported
2021-09-21
Evidence stage
ConstraintFailure, rollback, regulation or cost is suppressing adoption. Can lower an assessment or widen its uncertainty.
Tasks this bears on
Detecting and grading cancer
Finding cancer in biopsies and assigning its grade, such as the Gleason grade for prostate cancer.
Being augmented✓ Evidence-backed
Signing out the diagnosis
Integrating everything into the final report and answering for it.
Still human-led✓ Evidence-backed
Where this applies
United States. The FDA's De Novo decision for Paige Prostate says it is an adjunctive computer-assisted methodology whose output should not be used as the primary diagnosis, to be used only with the pathologist's complete standard-of-care evaluation. In its study, expected patient benefit from improved sensitivity was 7.3% of biopsy specimens with cancer, which the FDA says would likely be substantially lower per patient. The study data came from the developer.
What this means
The regulator let AI into cancer diagnosis on slides as a second pair of eyes, and wrote down that it is not the diagnosis.
What it does not yet show
One device for one organ in one country; later clearances may be broader.
What you can check
Open FDA De Novo summary DEN200080 and find "should not be used as the primary diagnosis".
Does it change the assessment?
No. The impact index is never moved by a single event. Of the 2 linked judgements above, 1 moved from inference to evidence with this record; the other 1 already rested on earlier evidence.
Source
U.S. Food and Drug Administration — De Novo decision summary DEN200080, Paige Prostate (decision date 09/21/2021) · verified 2026-09-30 · Claude (VOLO agent) · interpreted 2026-09-30 · Claude (VOLO agent)
Primary source — published by the party that did this, or the authority of record. No co-signature needed.
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