FDA stands up for Fonar's Indomitable
Nearly four years after its first unveiling at the 1996 RSNA meeting, Fonar's stand-up MRI scanner is now available for sale in the U.S. On Oct. 11, the company announced that the scanner, christened Indomitable, had cleared the FDA.The new
Nearly four years after its first unveiling at the 1996 RSNA meeting, Fonar's stand-up MRI scanner is now available for sale in the U.S. On Oct. 11, the company announced that the scanner, christened Indomitable, had cleared the FDA.
The new product is unique in its scanning approach. Rather than lying on a table between the magnets, patients stand in the 0.6-tesla field. The system, which is essentially a Quad 12000 scanner tipped on its side, is intended to better portray orthopedic conditions that occur when the patient is in a weight-bearing position.
When FDA clearance was announced, Fonar promised additional news. On Oct. 17, the company announced that Florida State University (FSU) and the Florida Chiropractic Association (FCA) were evaluating the scanner for possible use in their proposed Health and Human Performance Center and Laboratory. Fonar drew attention to a recent visit by FSU and FCA representatives to its Melville, NY, corporate headquarters.
Fonar executives could not be reached for comment, but according to a company press release, Joe Johnson, D.C., a chiropractor who is a past president of the FCA and a member of the development board of the College of Human Sciences at FSU, described the scanner as a "landmark and a significant breakthrough in diagnostic imaging. Now for the first time, we will be able to obtain MR images of a patient in the natural weight-bearing state, which can be far different from a nonweight-bearing image."
In an interview with SCAN, however, Johnson said that purchase of the equipment is only in the planning stage.
"Right now we are very strongly committed to moving forward, but I'm not quite sure of the time frame," he said. "We could be moving forward within a few months. It could be into next year."
Johnson believes initial clinical research might be done using the stand-up MRI unit now operating at the Fonar plant in Melville.
At press time, Fonar announced its first sale of Indomitable to a "scanning center on the East Coast." The buyer's name was not given.