Breakaway Imaging Receives FDA OK For Its O-arm Imaging System

Breakaway Imaging(TM), LLC, a leading developer of medical imaging systems for surgery, announces receipt of FDA 510(k) pre-market notification for their mobile O-arm(TM) Imaging System. The intended use references 2-D (fluoroscopic) imaging, 3-D (volumetric) imaging, and compatibility with image guided surgery systems.

"This platform has been designed from the ground up for a broad range of surgical applications, with special attention to orthopedic and spine procedures. Many of the procedures we do are three-dimensional in nature. Having on-demand, 3-D intra-operative imaging allows us to see the plane that is most important, the axial plane," comments Hansen Yuan, M.D., Professor of Orthopedics and Neurosurgery at SUNY Syracuse.

Kevin Foley, M.D., Professor of Neurosurgery at the University of Tennessee adds, "With the rapid development of minimally invasive instrumentation and techniques, never has intra-operative 3-D imaging been more important. This, coupled with robotically controlled 2-D fluoroscopy, will make the O-arm(TM) the ideal imaging system for these procedures."

The Company is initially targeting the O-arm(TM) for use in orthopedic and spine procedures. This regulatory milestone gives Breakaway yet another major step towards commercializing their technology.

Breakaway Imaging is committed to developing and marketing their innovative imaging technology, targeted at accelerating the adoption of advanced minimally invasive medical procedures, as a platform for use in numerous specialties. The O-arm(TM) combines single and multi-planar 2-D (fluoroscopy) with cone-beam volumetric ('CT') imaging. The system is mobile, able to access patients laterally, and is controlled using high precision robotics.