Groundbreaking Holographic System Receives FDA Clearance

By News Release

RealView Imaging Ltd. has received FDA 510(k) clearance for its HOLOSCOPE-i holographic system. The system creates spatially accurate, three-dimensional interactive medical holograms, based on data received from standard CT scans and 3D ultrasound systems. The HOLOSCOPE-i is the first and only medical holography system that provides physicians with a natural 3D visualization experience, allowing direct and precise interaction with dynamic holograms of the patient's true anatomy, floating in free space at hand's reach, prior to and during interventional procedures.

The HOLOSCOPE-i system has been designed and tailored to the specific needs of clinicians and interventionalists, with an “over-the-head” system configuration suspended above the physician, without the need for any head-mounted device, special eyewear or interaction tools. Based on the company's proprietary Digital Light Shaping technology, the HOLOSCOPE-i is the only commercial product that employs true interference-based volumetric holography (a Nobel Prize-winning technology) to create holograms with high spatial resolution in all three dimensions. This unique technological advantage allows natural 3D/4D visualization and prolonged use of the system without provoking fatigue, nausea or headache, which are the major problems with all currently available 3D stereoscopic visualization solutions, including Augmented Reality headsets, Virtual Reality headsets and stereoscopic screens.

“Having a real hologram of the heart in my hand, based on pre-operative CT and intra-procedure ultrasound, allows me to focus-in and fully understand the complexities of the patient's 3D anatomy,” said Dr. Elchanan Bruckheimer, Cath Lab Director at Schneider Children's Medical Center and Medical Director for RealView Imaging. “Using the holographic system, I can intuitively comprehend the dynamic spatial anatomical relationships of the cardiac valve leaflets, for example. I can literally touch, mark, locate, slice or define a path for the intervention. This technology provides me with more confidence, potentially resulting in shorter procedures and better outcomes.”

“There is a rapidly growing need for advanced visualization solutions in the world of medical imaging, driven by the huge trend to perform minimally invasive procedures that exclusively rely on imaging technologies,” says Shaul Gelman, CEO and Co-Founder of RealView Imaging. “The HOLOSCOPE-i delivers the next-generation of 3D interactive visualization tools that empower imaging-based medical interventions, allowing clinicians to intuitively understand the complex anatomy they are treating in a realistic and accessible way like never seen before.”

“After years of developing this incredible deep-technology, we are excited to bring this science-fiction solution to support real-world clinical practice,” said Dr. Shimon Eckhouse, RealView's Chairman of the Board. “Following this important FDA clearance, we are now focused on the commercialization of the HOLOSCOPE-i system in North America and are planning to expand our market reach to additional countries over the next year. I believe RealView can significantly impact the growing field of structural heart interventions, as well as additional clinical fields which rely on advanced imaging to deliver better and faster medical care.”

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Groundbreaking Holographic System Receives FDA Clearance.  Appl Radiol. 

By News Release| August 02, 2021
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