Mobius Imaging Receives FDA Approval for Airo Mobile Intraoperative CT

Mobius Imaging, a Massachusetts-based company, has received FDA 510(k) clearance for the Airo Mobile Intraoperative CT, a 32-slice computed tomography scanner. Mobius Imaging develops and manufactures medical imaging technology that can be seamlessly integrated into existing OR infrastructures. The company has an exclusive sales and service agreement with Brainlab AG, a German medical equipment manufacturer, for the distribution of the Airo Mobile Intraoperative CT System.

The Airo Mobile Intraoperative CT (AMICT) has a small footprint (1.5 m²) within the operating room and allows for imaging, convenient patient positioning and navigation. The improved imaging available, which includes full Hounsfield soft tissue imaging, with a scan volume of 51.2 cm x 100 cm, allows physicians to make optimal decisions during minimally invasive procedures. This versatile system is suitable for cranial, spinal and even trauma procedures. During spinal procedures, the entire spine can be imaged in a single scan and more of the anatomy can be visualized than a regular 3D C-Arm. The AMICT has a large bore size of 107 cm, an ultra-slim gantry with a size of 30.5 x 38cm, and a completely integrated Trumpf TruSystem 7500 surgical table system. The system has a high voltage generator, an optimized air cooling system and a built in battery pack. The mobility of the system can be attributed to the suspension controlled electrical drive that uses a single central wheel coupled with user friendly software that allows even one person to move the scanner from one room to another. There is also a front-view camera to prevent accidents during transport of the system.

Physicians can use a user friendly touch screen to interact with the system and to obtain optimal images. The scanner movement and positioning is further optimized through the Airo handheld system controller. The controller capabilities, along with the improved maneuverability of the AMICT, allows it to achieve any possible position for accurate imaging during any exam.

Product page: Airo Mobile Intraoperative CT…

Press release: Brainlab Announces FDA Clearance for Airo® Mobile Intraoperative CT…