Germany-based company Brainlab has announced that Mobius Imaging, a US-based company, has received 510(k) approval from the US Food and Drug Administration (FDA) to market the Airo mobile intraoperative CT system in the US.
Mobius Imaging is the developer and manufacturer of Airo Mobile Intraoperative CT and the system is distributed in the US under an exclusive sales and service agreement with Brainlab.
The CT system offers the imaging quality of a diagnostic CT scanner, full Hounsfield soft tissue imaging, with a scan volume of 51.2cmx100cm.
Airo Mobile Intraoperative CT system will offer high quality imaging for a comprehensive range of clinical procedures with its Airo gantry size and overall flexibility, and helps in overcoming conventional intraoperative limitations.
Mobius Imaging CEO Gene Gregerson noted Airo has been designed from the ground up and incorporates valuable practitioner insights.
"The 32-slice CT scanner offers an extra-large gantry opening of 107cm while at the same time possesses an extra small footprint so it can move easily from O.R. to O.R.
"The extra slim patented Airo gantry design makes it suitable for intraoperative imaging, enabling access to the patient during scanning and allowing for flexibility in patient setup.
"This flexibility and mobility make Airo a valuable extension for numerous additional environments," Gregerson added.
Airo mobile intraoperative CT is now available in the US and the company anticipates first shipments in the beginning of 2014.