• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

FDA Clears AI-Powered 3D CTA Reconstructions for Head and Neck Imaging

News
Article

The artificial intelligence (AI)-enabled software Lumina 3D reportedly provides reconstructions of computed tomography angiography (CTA) images of the head and neck in minutes.

While manual reconstruction of computed tomography angiography (CTA) images may take hours to complete, the Food and Drug Administration (FDA) has granted 510(k) clearance to Lumina 3D™, an artificial intelligence (AI) software that offers three-dimensional (3D) reconstructions of the head and neck within minutes.

Exclusively deployed on RapidAI’s Rapid Edge Cloud platform, Lumina 3D allows neuroradiologists to see enhanced visualization of a patient’s aortic arch, carotid artery tortuosity and neurovasculature on mobile devices, according to RapidAI.

FDA Clears AI-Powered 3D CTA Reconstructions for Head and Neck Imaging

Here one can see the use of the newly FDA-cleared Lumina 3D™ software. The AI-powered software provides 3D reconstructions within minutes of obtaining a computed tomography angiography (CTA) scan of the head and neck, according to RapidAI, the developer of Lumina 3D. (Image courtesy of RapidAI.)

The company emphasized that the enhanced imaging capabilities with Lumina 3D reduce procedure times through enhanced accuracy with pre-op planning and catheter selection.

“With a 98% DICE score and results available in minutes, Lumina 3D's level of automation, speed, and accuracy is unprecedented. We are entering an era of precise procedural planning where initial device selection is optimized for individual patient anatomy. … This is a technology that delivers not just better imaging, but potentially better outcomes,” said Daniel Gibson, M.D., a neuro-interventional radiologist affiliated with Goodman Campbell Brain and Spine in Carmel, Ind.

Recent Videos
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 2
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 1
Teleradiology and Breast Imaging: Keys to Facilitating Personalized Service, Efficiency and Equity
Radiology Study Finds Increasing Rates of Non-Physician Practitioner Image Interpretation in Office Settings
Can Fiber Optic RealShape (FORS) Technology Provide a Viable Alternative to X-Rays for Aortic Procedures?
Does Initial CCTA Provide the Best Assessment of Stable Chest Pain?
Nina Kottler, MD, MS
The Executive Order on AI: Promising Development for Radiology or ‘HIPAA for AI’?
Practical Insights on CT and MRI Neuroimaging and Reporting for Stroke Patients
Related Content
© 2025 MJH Life Sciences

All rights reserved.