Functional MRI got a boost in late April with the commercial launch of the Integrated Functional Imaging System-Standalone (IFIS-SA) developed by MRI Devices. The turnkey product, composed of an MRI head coil, audio and visual stimulator, and image processing workstation, is designed to support the visualization and analysis of MRI studies based on blood oxygen level dependent (BOLD) contrast.
The system was officially launched as a clinical product at the annual meeting of the American Society of Neuroradiology (April 21 to 27 in Boston) and the meeting of the International Society for Magnetic Resonance in Medicine (April 21 to 27 in Glasgow, Scotland). It is compatible with 1.5-tesla scanners from GE, Siemens, and Marconi and has been used experimentally with several 3-tesla units.
Until now, fMRI has been largely a research tool. Clinical studies indicate, however, that fMRI could play an important role in the diagnosis of neurological disorders, including epilepsy, Alzheimer’s disease, and Parkinson’s disease, as well as in planning surgery and monitoring patient recovery from stroke.
Possibly assisting this transition from research to clinical tool is the development of an integrated fMRI product. GE Medical Systems offers its own fMRI hardware-software solution, and other MRI vendors bundle some fMRI software with their scanners. In many cases, however, sites have themselves cobbled together the various components needed to conduct these studies—essentially a head coil interfaced with visual, audio, or tactile stimulators and software controllers and processors.
“We have put together a system that does it all for everybody,” said William Jace Dinehart, manager of functional imaging business at MRI Devices. “You don’t have to mess with interface boxes or figuring out what talks to what. Just roll it out and plug it in. You’re ready to do functional imaging in less than two hours.”
MRI Devices is selling the product through its own direct sales force, but it is also exploring possible OEM-supplier arrangements under which the system could be privately labeled by an MRI vendor. MRI Devices has 15 units operating at research sites. Since FDA clearance was gained on March 15, about a half dozen orders have been taken.
IFIS-SA is made up of an LCD video display, headphones, patient microphone, head stabilization unit, and a pair of button-activated hand-response units that convey patient responses to stimulation. Data flow through fiber-optic cable to and from a workstation.