LO
ConstraintProcess & self-service2017-04-12
Digital slides were authorised for primary diagnosis in 2017, but not for frozen sections, the US FDA's De Novo decision for Philips' system says
Pathologistoccupation page →
Event date / reported
2017-04-12
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
Frozen sections during surgery
Reading a rapidly frozen sample while the surgeon waits, and calling the result into the theatre.
Still human-led✓ Evidence-backed
Where this applies
United States. The FDA's De Novo decision authorised a whole-slide imaging system for pathologists to review and interpret digital images of formalin-fixed paraffin-embedded surgical pathology slides, and says it is not intended for use with frozen section, cytology or non-FFPE hematopathology specimens. In its study of 7,959 paired readings, 96.5% showed no major discordance between modalities or major discordance for both. It moves reading from glass to screen; it is not AI.
What this means
Digital pathology — the precondition for pathology AI — was authorised with frozen sections left out.
What it does not yet show
One system's intended use in 2017; later systems and guidelines may cover more.
What you can check
Open FDA De Novo summary DEN160056 and find "not intended for use with frozen section".
Does it change the assessment?
No. The impact index is never moved by a single event. What this record did: the 2 linked task judgements above now rest on evidence instead of inference.
Source
U.S. Food and Drug Administration — De Novo decision summary DEN160056, Philips IntelliSite Pathology Solution (decision date 04/12/2017) · 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.