Koning

The company has developed the first and only FDA-approved dedicated cone beam CT system for diagnostic use in breast imaging. Clinical trials have shown positive results since at least 2006–2008. The technology provides high-resolution, three-dimensional images without painful compression. It has regulatory approval in several countries including the US, Canada, Singapore, Australia, Thailand, and Qatar. Recent clinical adoption continues to expand globally.

Their AI-enhanced software further improves image quality by reducing noise/artifacts and increasing diagnostic accuracy.

Ongoing Series C fundraising aims to accelerate US deployment.

No specific published pivotal trial data or head-to-head studies are cited in these sources.

Key clinical value propositions include improved comfort vs mammography; better visualization of dense breasts; rapid scan time (~7 seconds per scan); potential for earlier/more accurate diagnosis.