AI in Medicine News ・ ⚖️ Device approvals and regulation

Brainomix Says Biomarker Qualification Is Next Step For Its FDA-Cleared Lung AI Software

Medtech Insight · 11/02 16:59 UTC

Quantitative CT from two platforms, Brainomix's e-Lung and a UCLA algorithm, both detected nintedanib's effect in the Phase III INBUILD substudy. Brainomix's Peter George said e-Lung's reticulovascular score alone predicted later mortality, but FVC remains the regulator's primary endpoint.

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