Mobius Imaging said yesterday it won FDA 510(k) clearance for its Airo Mobile CT imaging system designed for pediatric applications.
The Shirley, Mass.-based company said it previously won FDA 510(k) clearance in 2013 for non-pediatric imaging, and is designed for use in applications supporting brachytherapy, radiation therapy and surgical imaging.
The new clearance is an important milestone for the company, Mobius said, expanding the use of the Airo CT system into new segments and applications.
“There is an unmet need in being able to provide safe and reliable CT imaging for pediatric patients during various clinical procedures. 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,” Mobius Imaging CEO Gene Gregerson said in a prepared statement.