Evidence map›Paper›PMID 28584684›Full record

ReviewJournal of pathology informatics2017

Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA.

Esther Abels, Liron Pantanowitz

Abstract readReview
In one paragraph

Review in Journal of pathology informatics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

43 citing papers in PubMed.

  1. Article
  2. Digital transformation of pathology - the European Society of Pathology expert opinion paper.Virchows Archiv : an international journal of pathology · 2025
    Article
  3. Article
  4. Review
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  6. Article
  7. Review
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  10. Review
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  12. Review
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  15. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Esther AbelsPhilips, Digital Pathology Solutions, The Netherlands.
Liron PantanowitzDepartment of Pathology, University of Pittsburgh Medical Center, Pittsburgh, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a

Indexed as

De novodigitaldigital pathologyDigital Pathology AssociationFood and Drug Administrationpremarket approvalregulationwhole slide imaging

Identifiers

PMID28584684
PMCPMC5450449

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.