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Vendors including PathAI and Ibex offer algorithms that estimate staining extent, such as a Ki-67 or PD-L1 percentage, on a digitized slide. A pathologist checks the region and the number before it enters the report. This card does not restate concordance percentages, which are assay-specific and easy to over-read. The signed score remains a pathology result, not a model result.
Immunohistochemistry sign-out in a digital pathology lab, where the stain already has a clinical scoring scheme the tumor board expects.
No concordance figure is copied here. Treat vendor white papers as vendor-reported until an independent study matches the assay you actually run.
PathAI · 1. Feb. 2025 · Jahr 2025
In den Index aufgenommen 2. Juli 2026
Quelle öffnenEintrag für Bildung und Marktüberblick. Kein Rat und keine Empfehlung.
Pathologie
RegulatorischPaige Prostate marks a location on a digitized prostate biopsy slide that the model ranks as the most suspicious for cancer, after the pathologist’s own first look. FDA authorized it in 2021 as an adjunct. The output is not the diagnosis. The pathologist still signs out, using the full clinical context and any extra stains they choose to order.
Paige Prostate · Paige FullFocus
Bildgebung und Radiologie
RegulatorischIDx-DR, now marketed as LumineticsCore by Digital Diagnostics, was authorized to screen adults with diabetes for more-than-mild diabetic retinopathy without an eye specialist reading the photo first. A primary care team captures images on a specified retinal camera and the software returns a refer-or-rescreen result. It is not a complete eye examination. Pregnancy and several existing retinal conditions sit outside the labeled use.
LumineticsCore (IDx-DR) · Digital Diagnostics · Topcon NW400
Bildgebung und Radiologie
PubliziertThe MASAI trial in Sweden randomly assigned screening mammograms to AI-supported reading or standard double reading without AI. Transpara scored each exam and routed lower scores to a single reader and the highest score to double reading, with detection marks available on higher-risk exams. This card quotes the prespecified interim safety analysis, not a claim that every screening program should switch.
Transpara 1.7.0 · ScreenPoint Medical