Infervision vs Milvue

Milvue has a chest radiograph clearance, SmartChest K232410 under code QFM dated May 10, 2024, and Infervision's openFDA records are CT. Its six records name InferRead Lung CT.AI (K192880 and K240554, code OEB), InferRead CT Stroke.AI (K211179, QAS), InferOperate Suite (K250237 and K260973) and InferCare RECIST (K252261). A US hospital wanting chest radiograph AI under a clearance looks at Milvue, and one wanting lung nodules on chest CT or head CT triage looks at Infervision.

Milvue adds fracture detection with TechCare Trauma (K242171, QBS) and names RIS and PACS partners including Dedalus, Intrasense and Osimis, where Infervision calls itself PACS and RIS friendly with no vendor named. Milvue's suite is CE marked class IIa under MDR.

Outside the US, Infervision's InferRead DR Chest has an independent TB screening evaluation from Lusaka that reported sensitivity of 90.3 percent and specificity of 39.2 percent at a cut-off of 0.12. A TB screening program is the buyer for that chest film product, and a European emergency radiology group on a partnered PACS is the buyer for Milvue.