FDA grants 510(k) clearance to 4DMedical’s CT:VQ for respiratory diagnostics

The submission for CT:VQ was supported by a clinical validation package that spanned a variety of lung conditions.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to 4DMedical’s non-contrast, computed tomography (CT)-based ventilation-perfusion imaging technology, CT:VQ, for respiratory diagnostics.

This technology provides quantitative assessments of both ventilation and perfusion from standard chest CT scans.

4DMedical’s submission was supported by a clinical validation package that spanned a variety of lung conditions.

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