FDA clears updated software by Nanox.AI

The U.S. Food and Drug Administration (FDA) cleared an updated version of Nanox.AI’s HealthCCSng AI algorithm for identifying patients at risk of coronary artery disease.

HealthCCSng is designed to automatically measure coronary artery calcium (CAC) on nongated, noncontrast CT scans. HealthCCSng V2.0 introduces the following new features, the vendor said:

  • Zero CAC Category: This enables clinicians to distinguish between patients with zero and low CAC levels and joins existing low, medium, and high CAC categories.
  • Numerical CAC Scoring: The numerical CAC score is now provided alongside the CAC category in the software’s results interface during cardiac risk assessments.
  • CAC Category Configuration: Users can now adjust the lower and upper bounds for the low (1-99 Hounsfield units (HU) by default), medium (100-399 HU by default), and high (400+ HU by default) categories of CAC scores.

Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nano-X Imaging (Nanox).

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