RealView Imaging Receives FDA for Holoscope-i Medical Holographic Imaging System
November 15, 2021 – RealView Imaging Ltd. Recently 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 viewing experience, allowing direct and precise interaction with dynamic holograms of the patient’s true anatomy, floating in free space to at hand, before and during interventional procedures.
The Holoscope-i system has been designed and tailored to the specific needs of clinicians and interventionists, with an ‘over the head’ system configuration suspended above the physician, without the need for any head mounted devices. , special glasses or interaction tools. Based on the company’s proprietary Digital Light Shaping technology, the Holoscope-I uses true interference-based volumetric holography (a Nobel Prize-winning technology) to create high spatial resolution holograms in all three dimensions. This unique technological advantage enables natural 3D / 4D viewing and prolonged use of the system without causing fatigue, nausea or headaches, which are the major issues with all currently available 3D stereoscopic viewing solutions, including headsets. augmented reality, virtual reality headsets and stereoscopic screens.
Earlier this year, the company extended its Series C financing round to $ 15 million. 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 the roundtable, including investors in serial technology and medicine, Dr Shimon Eckhouse and Zohar Gilon.
The company was founded by Aviad Kaufman, Shaul Gelman and Professor Carmel Rotschild, with an initial investment led by Dr Shimon Eckhouse, Chairman of the Board. Along with the development of core holographic technology, RealView has generated a strong global IP portfolio (39 patents, 28 granted to date). The first human clinical study to assess the feasibility of live 3D holographic imaging in a clinical environment was successfully performed a few years ago with a prototype holographic system at the Schneider Children’s Medical Center in Israel, in collaboration with Philips Healthcare. The company recently completed the installation of the Holoscope-i commercial setup at Schneider Children’s and continues to perform collaborative clinical work at this major medical center.
“Having a true hologram of the heart in my hand, based on a preoperative CT scan and intraoperative ultrasound, allows me to focus and fully understand the complexities of the patient’s 3D anatomy,” said Dr. Elchanan Bruckheimer, catheterization laboratory director of Schneider Children’s Medical Center and medical director of RealView Imaging. “Using the holographic system, I can intuitively understand the dynamic spatial anatomical relationships of heart valve leaflets, for example. I can literally touch, mark, locate, slice or define a path for the intervention. This technology gives me more confidence, which can lead to shorter procedures and better results.
“There is a growing need for advanced visualization solutions in the world of medical imaging, driven by the huge trend to perform minimally invasive procedures that rely exclusively on imaging technologies,” said Shaul Gelman, CEO and co-founder of RealView Imaging. “The Holoscope-i offers the next generation of interactive 3D visualization tools that enable imaging-based medical interventions, enabling clinicians to intuitively understand the complex anatomy they are dealing with in a realistic and accessible manner such as never before. “
“After years of developing this incredible cutting edge technology, we are excited to bring this sci-fi solution to support real-world clinical practice,” said Dr. Shimon Eckhouse, Chairman of the Board of Directors of RealView . “Following this important FDA clearance, we are now focused on commercializing the Holoscope-i system in North America and plan to expand our market to other countries over the next year. I believe RealView can have a significant impact on the growing field of structural heart interventions, as well as other clinical areas that 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, adapting its proprietary technology to multiple clinical applications. The company’s next product, the Holoscope-x, projects 3D holographic images inside the patient’s closed body (in situ), making the patient literally transparent. This patented product, currently under development, is specially designed to enable spatially precise and minimally invasive intracorporeal procedures.
For more information: https://realviewimaging.com/
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