This approval allows Brainlab to begin installation of the systems sold in the European Union.
Airo incorporates the largest gantry opening on the market, lending itself particularly to cranial, spine and trauma procedures. The portable scanner provides reproducible high-resolution images.
Airo also connects seamlessly and automatically with Curve Information Guided Surgery by Brainlab, allowing for immediate surgical navigation on newly acquired images in the OR.
Brainlab president and CEO Stefan Vilsmeier said in light of the enormous market response Airo has already experienced around the world, the company is eager to begin installation and use in Europe.
"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," Vilsmeier added.
Mobius Imaging CEO Gene Gregerson said receiving CE Mark approval for company’s flagship product, Airo, is a significant milestone for 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," Gregerson added.
According to Brainlab, the first European shipments of Airo are expected in April 2014.
Image: The Airo Mobile Intraoperative CT System. Photo: courtesy of Brainlab/ Business Wire.
