Nanovis received the first FDA 510(k) clearance for a bioceramic nanotube surface that demonstrates FDA's requirements for nanotechnology. The technology is planned to be used with the company's entire spinal implant line.
“We are delighted to receive such an important designation for this new class of nanotechnology. With this clearance we can rapidly apply this technology to our entire spinal implant portfolio so that we can help as many patients as possible and promote sales growth for the long-term.” said Nanovis CEO, Matt Hedrick.
Presently the company is commercializing a deeply-porous Ti scaffold available with the FortiCore line of interbody devices, an anterior cervical plating system and open and MIS pedicle screws. Its pipeline includes a bactericidal surface technology and a localized infection technology targeting anti-microbial resistant bacteria, both in pre-clinical studies.