August 2, 2021 – RealView Imaging Ltd., an Israeli start-up working in the field of interactive live holography, has today announced that it has received FDA 510(k) clearance for its HOLOSCOPE-i holographic system. According to the company, the system creates spatially accurate, three-dimensional interactive medical holograms, based on data received from standard CT scans and 3D ultrasound systems, granting physicians direct and precise interaction with dynamic holograms of a patient’s true anatomy.
Commenting on the announcement, 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.”
The HOLOSCOPE-i system’s design features 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 employs true interference-based volumetric holography to create holograms with high spatial resolution in all three dimensions. The company stated that this technological advantage allows for natural 3D/4D visualization and prolonged use of the system without provoking fatigue, nausea or headache.
“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.”
Earlier this year the company expanded its Series C financing round to USD $15M. Along with the development of its core holographic technology, RealView has generated a global IP portfolio of 39 patents (28 granted) to date. The company’s 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 also recently completed the installation of the HOLOSCOPE-i commercial configuration at Schneider Children’s and is continuing to perform collaborative clinical work at the medical center.
“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,” said 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.”
The company’s next product, the HOLOSCOPE-x, projects 3D holographic images inside of a closed patient’s body (in situ), making the patient appear transparent. The patented product, currently under development, is designed to enable in-body spatially-precise minimally-invasive procedures.
For more information on RealView and its holographic medical imaging technology, please visit the company’s website.
Image credit: RealView