RealView Imaging’s Holoscope-i Holographic System Cleared by FDA

August 2, 2021—RealView Imaging Ltd., an Israel-based developer of medical holographic technology announced that it has received FDA 510(k) clearance for its Holoscope-i holographic system. The company stated that the system creates spatially accurate, three-dimensional (3D) interactive medical holograms, based on data received from standard CT scans and 3D ultrasound systems.

According to RealView Imaging, the Holoscope-i 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, before and during interventional procedures.

The company stated that the Holoscope-i system has been designed for the specific needs of clinicians and interventionalists with an “over-the-head” system configuration suspended above the physician, without the need for head-mounted devices, special eyewear, or interaction tools.

The Holoscope-i system is based on the company’s Digital Light Shaping technology. It employs interference-based volumetric holography to create holograms with high spatial resolution in all three dimensions. The technology allows natural 3D/4D visualization and prolonged use of the system without provoking fatigue, nausea, or headache, noted the company.

RealView Imaging recently completed the installation of the Holoscope-i commercial configuration at Schneider Children’s Medical Center in Petah Tikva, Israel, where early feasibility studies were conducted on the technology. Elchanan Bruckheimer, MBBS, who serves as Medical Director for RealView Imaging, is Catheterization Lab Director at Schneider Children's Medical Center.

“Having a real hologram of the heart in my hand, based on preoperative CT and intraprocedure ultrasound, allows me to focus-in and fully understand the complexities of the patient’s 3D anatomy,” commented Dr. Bruckheimer in the company’s press release. “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.”

Additionally, the company noted that earlier this year it expanded its series C financing round to $15 million. The initial financing round of $10 million was announced in July 2020.

Participants in this round included Judith and Kobi Richter, the Lowy Medical Research Institute, Rami Ungar, OurCrowd VC, and Club100Plus Investments Group. Also, the majority of the company’s existing shareholders including Shimon Eckhouse, PhD, Chairman of the Board of the company, and Zohar Gilon, participated in this round of financing.