Digital Diagnostics vs Milvue

Milvue is a Paris vendor selling radiograph reading aids: fracture and dislocation flags, bone measurements, and a report drafting tool the vendor itself says is not a medical device. It claims 600+ sites in 25 countries and 70 million analyses per year. The product is CE class IIa under the EU MDR through notified body BSI, and two US 510(k)s cover TechCare Trauma and SmartChest. A hospital radiology service or imaging group is the buyer.

LumineticsCore grades retinal photos. The vendor's history page says CMS changed the wording of CPT 92229 in early 2023 from "automated" to "autonomous diagnosis." The vendor points to that code for billing the result in a US clinic that treats adults with diabetes. An ISO 13485:2016 certificate appears in the site footer.

Milvue hands a flagged radiograph to a radiologist, whereas the vendor says LumineticsCore returns its retinal diagnosis straight to the clinic treating the patient.