FDA OKs medical device made by Bowdoin company
FHC Inc., headquartered in Bowdoin, has received clearance from the Food and Drug Administration for the Guideline 4000 5.0 electrophysiological recording and stimulation system. This makes the Guideline 5 available for use in the U.S., the European Union and Australia.
The Guideline 5 is FHC’s fourth iteration of the Guideline series, which has been used at numerous hospitals around the world since 2001.
The Guideline 5 provides high-quality, research-grade recordings on microelectrodes and macroelectrodes. Improved signal quality and decreased noise susceptibility have been achieved through a new design that moves digital interfaces closer to the sterile field, according to the company. The device provides neurosurgical teams with a powerful microelectrode recording and stimulating system in a compact package.
FHC Inc. has supplied equipment for neuroscience since 1970. It designs, manufactures and internationally markets products for neuroscientists, neurologists and neurosurgeons. The company is headquartered in Bowdoin and operates globally with locations in Pennsylvania, South America and Europe.
From a contributed news release
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