Nanox gets FDA nod for HealthFLD liver attenuation software

Nanox's deep-learning medical imaging analytics subsidiary, Nanox AI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for HealthFLD liver attenuation software.

HealthFLD provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans.

The company highlighted HealthFLD's performance in a 2023 study of nearly 3,000 patients, which found that the software achieved a sensitivity of 77.8% and specificity of 93.2% at less than 80 HU.

This marks the third product in Nanox AI’s suite of population health software products to become commercially available.

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