LumiNE US Software Receives FDA Clearance for Surgical Planning

We are pleased to announce that our LumiNE US software has received clearance from the U.S. Food and Drug Administration (FDA) for use in surgical planning.

LumiNE US is designed to provide medical professionals with cutting-edge tools for visualizing anatomy and pathology. By converting 2D patient imaging into 3D models, the software empowers neurosurgeons and other qualified professionals with enhanced insights during surgical preparation. The platform integrates advanced technologies, including Augmented Reality (AR) and Artificial Intelligence (AI), to revolutionize the way medical imaging is used in clinical environments.

Key Features of LumiNE US:

• 3D Model Creation: LumiNE US converts 2D MRI and CT scans into 3D models to support surgical planning.
• Augmented Reality: The platform enables AR-based visualization of patient data via wireless Head-Mounted Displays (HMDs), providing a more immersive experience.
• Segmentation Capabilities: The software utilizes an AI-based algorithm for semi-automatic segmentation of known tumors, brain structures, skin, and ventricles from contrast-enhanced MR scans. For CT scans, a threshold-based segmentation approach is applied.
• Streamlined Workflow: LumiNE US is specifically tailored for use by (neuro)surgeons, residents, and other qualified medical professionals within hospital settings.

While LumiNE US is a powerful tool for visualizing medical images, it is important to note that it is intended solely for the preparation phase of surgery, rather than for diagnostic purposes. Its capabilities are designed to aid in surgical planning for previously diagnosed conditions.

This FDA clearance underscores our ongoing commitment to advancing surgical planning through innovative technology, and we are excited about the positive impact LumiNE US will have on the future of healthcare.

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