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RealView Imaging Ltd. gets FDA clearance for HOLOSCOPE-i holographic system

Press releases may be edited for formatting or style | August 03, 2021 Business Affairs
YOKNEAM, Israel, Aug. 2, 2021 /PRNewswire/ -- RealView Imaging Ltd. today announced that it 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 which 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 which 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.

Earlier this year the company expanded its series C financing round to $15M. Participants in this round included notable investors Judith and Kobi Richter, the Lowy Medical Research Institute, Rami Ungar, OurCrowd VC and Club100Plus Investments Group. The majority of the company's existing shareholders also participated in this round, including serial technology and medical investors Dr. Shimon Eckhouse and Zohar Gilon.

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The company was founded by Aviad Kaufman, Shaul Gelman and Prof. Carmel Rotschild, with a seed investment led by Dr. Shimon Eckhouse, the Chairman of the Board of Directors. Along with the development of the core holographic technology, RealView has generated a strong global IP portfolio (39 patents, 28 granted to date). The first-in-human clinical study to evaluate the feasibility of live 3D holographic imaging in a clinical setting was successfully performed a few years ago with a prototype holographic system at Schneider Children's Medical Center in Israel, in collaboration with Philips Healthcare. The company has recently completed the installation of the HOLOSCOPE™-i commercial configuration at Schneider Children's and is continuing to perform collaborative clinical work at this important medical center.

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