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GeneralDevices & AI clearances

FDA clears Medis QGuideCT (1.0) via 510(k)

U.S. FDA granted 510(k) clearance to QGuideCT (1.0) from Medis Medical Imaging Systems BV under the Radiology committee (product code QIH).

U.S. FDA
Musculoskeletal (MSK)PediatricAI / InformaticsNews

FDA clears BoneXpert AI for automated bone age in pediatric radiographs

FDA clears Visiana’s BoneXpert AI for bone age assessment in ages 2–21. In a multicenter study, the software had a root mean square error of 0.55 years vs 0.76 for radiologists, and fewer errors >1.5 years (1.7% vs 6.4%). On-premise workflow keeps images local.

Radiology Business
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