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News Release - August 2, 2021
RealView Imaging Ltd., World Leader in Medical Holography, Receives FDA Clearance for its Groundbreaking HOLOSCOPE(TM)-i Holographic SystemYOKNEAM, Israel, Aug. 2, 2021 -- (Healthcare Sales & Marketing Network) -- 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.
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.
"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."
RealView Imaging's vision is to leverage its pioneering position to globally lead the field of Medical Holography, scaling its proprietary technology to multiple clinical applications. The company's next product, the HOLOSCOPE™-x, projects 3D holographic images inside the closed patient's body (in situ), making the patient literally transparent. This patented product, currently under development, is uniquely designed to enable in-body spatially-precise minimally-invasive procedures.
Source: RealView Imaging
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