Brainlab Announces FDA Clearance for Airo® Mobile Intraoperative CT
Airo Size and Flexibility Suitable for Wide Range of Intraoperative Imaging Options
Chicago, Illinois, October 9, 2013 – Brainlab, a leading software technology company with a longstanding dedication to innovation in the fields of neuro- and spinal surgery, announced today the 510(k) clearance from the US Food and Drug Administration (FDA) to market Airo Mobile Intraoperative CT in the US. The FDA clearance was received by Mobius Imaging®, LLC 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 CurveTM 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 O.R. 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 now 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 51.2cm x 100cm.
“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 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.”
An integrated O.R. table system from TRUMPF is the foundation for reproducible patient positioning with defined movement of the gantry relative to the patient. A variety of table tops allow surgeons to accommodate a range of procedures.
Airo is available now in the US and first shipments are expected beginning of 2014.
Brainlab develops, manufactures and markets software-driven medical technology that supports targeted, less-invasive treatment. Core products are image-guided systems and software that provide real-time information used for surgical navigation and radiosurgical planning and delivery.
Brainlab technology drives collaboration between hospitals and clinicians from a wide variety of subspecialties—from neurosurgery and oncology to orthopedics, ENT, CMF and spine & trauma. This integration delivers better access to improved and more efficient treatment. Founded in 1989, privately held Brainlab group has about 5,000 systems installed in about 80 countries. Based in Munich, Germany, Brainlab employs 1,070 people in 17 offices worldwide.
To learn more, visit www.brainlab.com.
About Mobius Imaging, LLC
Mobius Imaging develops, designs and manufactures advanced imaging technologies that fit seamlessly into existing medical workflows. The company’s approach to technology – Intelligent Imaging – is designed to give healthcare practitioners the crisp, clear images they want, whenever and wherever they want them, without adding time or complexity to the procedure. From the OR to the ER to clinical settings of all kinds, Intelligent Imaging expands possibilities. Founded in 2008, the company maintains a broad IP portfolio. Its first commercial product, the Airo Mobile Intraoperative CT System, is distributed under an exclusive sales and service agreement with Brainlab.
To learn more, visit www.mobiusimaging.com.