Realview Imaging gains FDA approval for Holoscope-i system

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RealView Imaging has announced that it has received US Food and Drug Administration (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 computed tomography (CT) scans and 3D ultrasound systems.

The Holoscope-i system has been designed 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 device employs interference-based volumetric holography to create holograms with high spatial resolution in all three dimensions.

Earlier this year the company expanded its series C financing round to US$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.

“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 Elchanan Bruckheimer, cath lab director at Schneider Children’s Medical Center, Petah Tikva, Israel, 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.”


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