Mobile Intraoperative CT System Cleared for Use in United States

A computed tomography (CT) system has been designed for a wide range of intraoperative imaging applications.

Brainlab (Feldkirchen, Germany), a software technology company focussed in the fields of neuro- and spinal surgery, reported the 510(k) clearance from the US Food and Drug Administration (FDA) to market Airo Mobile Intraoperative CT in the United States. The FDA clearance was received by Mobius Imaging, LLC (Ayer, MA, USA), the developer and manufacturer of Airo Mobile Intraoperative CT on September 26, 2013.

“The market was ready for innovation in the surgical space from an advanced imaging perspective,” said Stefan Vilsmeier, president and founder at Brainlab. “Brainlab is now able to offer mobile CT imaging which can be used in combination with Curve Image-Guided Surgery, helping to improve customer workflows while expanding clinical indications for intraoperative imaging. Access to real-time information is transforming the surgical space and becoming integral to daily life in the OR [operating room]. Airo is a great example of how Brainlab is and will continue to maximize the impact of intraoperative information for surgical decision making and the well-being of patients.”

Airo gantry size and overall flexibility allow facilities to offer high quality imaging for a comprehensive range of clinical procedures while helping overcome conventional intraoperative limitations. An all-in-one solution, Airo offers the imaging quality of a diagnostic CT scanner, full Hounsfield soft tissue imaging, with a scan volume of 51.2 cm x 100 cm.

“Airo has been designed from the ground up and incorporates valuable practitioner insights,” said Gene Gregerson, CEO, Mobius Imaging LLC. “Airo changes the game in terms of size, access and mobility in intraoperative imaging. We took an intelligent imaging approach, which means everything about the technology had to answer clinical need and be incorporated intuitively into everyday clinical practice. The 32-slice CT scanner offers an extra-large gantry opening of 107 cm while at the same time possesses an extra small footprint so it can move easily from OR to OR. 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.”

An integrated OR table system from Trumpf (Ditzingen, Germany) creates the foundation for reproducible patient positioning with defined movement of the gantry relative to the patient. A variety of tabletops allow surgeons to accommodate a range of procedures.

Related Links:
Brainlab
Mobius Imaging
Trumpf