FDA Clearance for Novel 3-D Interactive Virtual Reality System

An innovative true 3-D real-time interactive holographic system that enables clinicians to visualize and interact with tissues and organs in open 3-D space has received US Food and Drug Administration 510(k) clearance.

The system is integrated into a DICOM diagnostic-grade workstation and enables readers to identify an area of interest in a 3-D Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) data set, for example, and manipulate it using hand-directed stylus in a real-time interactive holographic system.

The True 3D (t3D) Viewer 1.0 platform was developed by EchoPixel (Mountain View, CA, USA) and provides an enhanced understanding of human anatomy, improved visual perception, and tolerance to image noise. In terms of workflow, the t3D can identify the anatomy of interest, and pinpoint it with regard to surrounding anatomy including depth information and contours. The reader can then use the stylus to dissect malformations for further analysis.

The t3D takes sharing 3-D annotated medical data and expertise to a new level, including expert-derived methodologies for radiological and surgical procedures. EchoPixel also intends to share these 3-D images with patients giving them a better insight into their own anatomy.

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