Mobius Imaging has gained CE Mark approval for its Airo Mobile Intraoperative CT System, distributed under an exclusive sales and service agreement with German company Brainlab. The CE Mark allows Brainlab to begin installation of the systems sold in the European Union.
In the press release issued to confirm CE marking, Airo is described a unique system that advances health care delivery by producing high-quality CT images that enhance surgical decision-making and support minimally invasive surgery. The portable scanner provides reproducible high-resolution images, thanks to its integrated O.R. table column by TRUMPF and 32-slice helical scan detector array. Airo boasts the largest gantry opening on the market, lending itself particularly to cranial, spine and trauma procedures. Airo also connects seamlessly and automatically with Curve™ Information Guided Surgery by Brainlab, allowing for immediate surgical navigation on newly acquired images in the O.R.
The first European shipments of Airo are expected in April 2014.
“In light of the enormous market response Airo has already experienced around the world, we are eager to begin installation and use in Europe,” said Stefan Vilsmeier, President and CEO at Brainlab. “We are dedicated to meeting the growing demand for real-time imaging in the O.R. to improve and expedite clinical decision-making which benefits both the patient and the surgical team. Airo surpasses this demand and we are pleased to now be able to provide our European customers with this advanced imaging system.”
for Mobius Imaging
“Receiving CE Mark approval for our flagship product, Airo, is a significant milestone for Mobius Imaging,” said Gene Gregerson, CEO of Mobius Imaging. “We are proud of the extensive research and usability put into Airo that resulted in a Red Dot award-winning product design. Airo has been showcased at many European congresses and customers are excited to have the opportunity to bring the product’s benefits to their patients.”
Source: Brainlab, AG.