Date: Mar 07, 2013 Source: Company Data (
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BENSALEM, PA, April 1, 2013 ‐ NeuroDx Development, a privately held medical device company, has received U.S. FDA 510(k) premarket notification clearance for the latest generation of its CSF shunt flow detection system, ShuntCheck III.
"FDA clearance of ShuntCheck III is a major milestone in the development of our technology," said NeuroDx founder and CEO, Frederick J Fritz. "ShuntCheck III features an improved sensor and more user friendly software which runs on Windows 7 tablet or laptop computers, but most importantly, ShuntCheck III includes Micro-Pumper, a component which generates a temporary increase in shunt flow in patent but temporarily non-flowing shunts."
"We are excited to bring this new, improved clinical tool to the US market later this year," said Fritz.
NeuroDx Develop (www.neurodx.com) is a privately held, diagnostic device company focused on addressing unmet clinical needs in the neurosurgery market. NeuroDx is headquartered in Bensalem, PA.