Brainlab announces FDA clearance for Airo Mobile Intraoperative CT

Brainlab announces FDA clearance for Airo Mobile Intraoperative CT

Brainlab announced recently the 510(k) clearance from the U.S. Food and Drug Administration to market Airo Mobile Intraoperative CT in the U.S. The FDA clearance was received by Mobius Imaging, LLC the developer and manufacturer of Airo Mobile Intraoperative CT on Sept. 26.

“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. 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 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.

An integrated OR table system from Trumpf is 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.

Airo is available in the U.S. and shipments are expected beginning in 2014.