AI-supported reading in the MASAI mammography trial
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The 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.
Klinischer Rahmen
Population mammography screening for women aged 40–80 at four sites in southwest Sweden, inside the existing screening invitation.
Werkzeuge und Anbieter
Transpara 1.7.0
ScreenPoint Medical
Was die Quelle berichtete
In the interim analysis of about 80,000 women (Lancet Oncology, 2023), cancer detection was 6.1 per 1,000 with AI support and 5.1 per 1,000 with standard reading (ratio 1.2, p=0.052). False-positive rates were 1.5% in both arms. Screen-reading workload fell by 44.3%. Interval cancer, the primary endpoint, was left to later follow-up.
Quelle
Lång et al., The Lancet Oncology · 1. Aug. 2023 · Jahr 2023
IDx-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
Several cleared products flag possible urgent findings on a chest radiograph, such as pneumothorax, and move that study up a reading worklist. Names often cited for this job include Lunit INSIGHT CXR, Annalise Enterprise CXR, and qXR. This card describes the shared workflow, not a head-to-head, and it does not pool accuracy numbers across vendors. A flagged study still needs a radiologist’s report.
Viz.ai ContaCT analyzes brain CT angiography and can text a neurovascular specialist when it suspects a large-vessel occlusion, in parallel with the usual read. FDA permitted marketing in 2018 as notification software. The specialist still reviews full images on a diagnostic workstation. The product is not a diagnosis and not a treatment decision.