Shirley, MA. (April 26, 2018) – Mobius Imaging, LLC, announced today that it has received 510(k) clearance for its Airo®Mobile CT Imaging System for pediatric applications. The Airo Mobile CT Imaging System previously received 510(k) clearance in 2013 for non-pediatric imaging and has become a market leader in intraoperative, image guided procedures in neuro-spine surgery. Airo diagnostic images also continue to be utilized for supporting applications in brachytherapy, radiation therapy and surgical imaging. The ability to provide Airo Mobile CT imaging for pediatrics is an important milestone in the Company’s ability to offer solutions for additional clinical segments and applications. Pediatric patients can now receive the clinical benefits of Airo CT imaging for diagnostic and intraoperative procedures.
“There is an unmet need in being able to provide safe and reliable CT imaging for pediatric patients during various clinical procedures” explained Gene Gregerson CEO of Mobius Imaging. “CT systems must be designed and validated for safety and efficacy using different protocols than would be appropriate for adult patients. We are delighted to now be able to offer the benefits of Airo Mobile CT imaging to clinicians and their pediatric patients.”
About Mobius Imaging
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 now has over 130 Airo installations in 23 countries since 2014. Mobius Imaging is a registered trademark of Mobius Imaging, LLC.
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