nView medical Inc., a Salt Lake City early stage start-up, has received 510(k) clearance from the FDA for its interventional fluoroscopic X-ray system called the nView s1.
In a July 13, 2019 press release, the company said its technology integrates, “the latest developments in low-dose X-ray imaging with intelligent imaging algorithms to provide fluoroscopic and multiplanar views derived from tomographic reconstructions. The views can be used by surgeons to accurately assess the anatomy and placement of implants during spinal and orthopedic procedures.
nView s1
According to FDA documents, “The nView is a cone beam computed tomography X-ray system and a fluoroscopic X-ray imaging system consisting of two mobile units: a mobile C-arm and a monitor cart.”
“The mobile C-arm has a fixed anode x-ray tube, a high voltage generator, x-ray controls, and a mechanical “C” shaped structure “which supports the x-ray tube and generator and the image receptor flat panel detector.”
The mobile monitor cart “connects to the mobile C-arm by USB and HDMI cables and which integrates the flat panel display monitors and user controls.”
“The result is the visualizing of the human anatomy in both 2D and 3D. The x-ray tube powered by the generator produces x-rays, which image the patient under control of the user, at the direction of a physician.”
Indication
The device, according to the FDA documents, “is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.”
“The device is indicated to image human anatomy up to 30 cm thickness.”
The FDA took about six months to review the notification from the company. As always, the cleared device is declared “substantially equivalent” to a predicate device. In this case the predicate is the Ziehm Vision RFD 3D.
The differences described to the predicate include: “the subject device having lower temporal fluoroscopic views generated from tomographic reconstructions, a different acquisition geometry, a lower powered x-ray tube, and faster acquisition and reconstruction times.”
Adult and Pediatric Populations
Company COO Lisa Last noted the clearance “as a fluoroscopic and tomographic imaging system for adult and pediatric populations, our low-dose operation brings a unique opportunity to increase precision via 3D imaging while minimizing radiation exposure.”
The company says that tests show that patient absorbed radiation dose is 0.11 mSv per 3D image.
Cristian Atria, the company’s founder and CEO said the future of surgery “will be enabled by automation and quantification. nView s1 is our first step in that direction.”
The start-up company has some impressive medical and financial backers including the National Science Foundation, the National Institutes of Health, the State of Utah, the National Consortium for Pediatric Device Innovation, MedtechInnovator, Kevin Foley, M.D., and Fusion Fund in Palo Alto, California.
