FDA clears Mobius Imaging ’ s Airo Mobile CT imager for pediatric use

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. The post FDA clears Mobius Imaging’s Airo Mobile CT imager for pediatric use appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance mobiusimaging Source Type: news

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Source: American Journal of Clinical Oncology - Category: Cancer & Oncology Tags: Original Articles: Gynecologic Source Type: research
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Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research
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Source: European Urology - Category: Urology & Nephrology Source Type: research
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Source: Acta Oncologica - Category: Cancer & Oncology Authors: Tags: Acta Oncol Source Type: research
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Source: Cancer Gene Therapy - Category: Cancer & Oncology Authors: Source Type: research
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Source: Journal of Contemporary Brachytherapy - Category: Cancer & Oncology Tags: J Contemp Brachytherapy Source Type: research
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Source: Physics in Medicine and Biology - Category: Physics Authors: Tags: Phys Med Biol Source Type: research
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