Aidoc vs Infervision

Infervision's InferRead CT Lung detects pulmonary nodules on CT (K192880, 2020, a CADe record). The vendor page adds lobe density and volume analysis and follow-up registration with volume doubling time, and marks nodule growth, emphysema and coronary calcium quantification for investigational use only. InferRead CT Stroke.AI (K211179) is its triage record, for hemorrhage on head CT. The chest X-ray product, InferRead DR Chest, has no openFDA record under the three applicant names, and an independent Zambian TB screening study of it measured 90.3% sensitivity and 39.2% specificity at a 0.12 cut-off. The pages call it PACS and RIS friendly, on-premise or cloud. Infervision serves lung screening programs and TB programs abroad. Aidoc's buyer is an emergency radiology group that wants PE and body CT triage. Its modules include a PE tool and CARE body CT triage (K252970), and it states ISO 13485:2016, MDSAP and EU MDR 2017/745. Infervision trails for that group, since its triage record addresses head CT hemorrhage.