The FDA has cleared a system that creates accurate, three-dimensional holograms of a patient’s organs, giving surgeons a new opportunity to interact with their anatomy and orient themselves prior to any procedure.
RealView Imaging’s Holoscope-i assembles its holograms from CT and 3D ultrasound scans and projects them from a device suspended over the surgeon’s head. This allows the user to manipulate the image with their hands, without having to wear augmented reality headsets or other equipment.
Users can rotate the image for a 360-degree view and quickly measure the distance between two points. This functionality makes it easy to gauge the size and placement of a new heart valve or chart a course through a patient’s blood vessels.
"Having a real hologram of the heart in my hand based on pre-operative CT and intraprocedure ultrasound, allows me to focus in and fully understand the complexities of the patient's 3D anatomy," RealView’s medical director, Elchanan Bruckheimer, said in a statement.
"Using the holographic system, I can intuitively comprehend the dynamic spatial anatomical relationships of the cardiac valve leaflets, for example,” added Bruckheimer, who also serves as director of the cath lab at Schneider Children's Medical Center in Israel, where the company’s first-in-human clinical study was conducted in a 2013 collaboration with Philips Healthcare.
Now with a 510(k) clearance in hand, RealView will now focus on the commercial rollout of what it describes as a “science-fiction solution to support real-world clinical practice,” according to board chairman Shimon Eckhouse. The company also plans to expand its reach to Europe and additional countries over the next year.
Earlier this year, RealView expanded the $10 million series C round launched in 2020 up to $15 million, with backing from Judith and Kobi Richter, the Lowy Medical Research Institute, Rami Ungar, OurCrowd VC and Club100Plus Investments Group.
"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 co-founder and CEO Shaul Gelman.
Looking ahead, the company’s next product aims to project 3D holographic images showing the inside of the patient’s body as they lie on the operating table, making them appear transparent during minimally invasive procedures.