Third Wave receives FDA clearance of pharmacogenetic test
It is the first pharmacogenetic test to be approved by the FDA for use as a companion diagnostic to a specific drug therapy. The test is c...Neurognostics receives special FDA clearance for MindState fDAD
., a Wisconsin company specializing in functional Magnetic Resonance Imaging (fMRI) products and services, announced today that the Food and Drug Administration (FDA) issued a Special 510(k) approval for market clearance of its trademarked MindState fDAD. MindState fDAD had previously received clearance in Febr...GE Medical Systems Receives FDA Clearance for New MRI System
WAUKESHA, WI - GE Medical Systems, a unit of General Electric Company, announced today that it has received clearance by the U.S. Food and Drug Administration to begin marketing its new 3.0 Tesla ultra-short magnetic resonance imaging (MRI) system. The Signa EXCITE 3.0T combines the increased speed and higher resolution of an ultra-high field system with the breadth of imaging capabilities found...Prozac Gets Conditional Clearance For Treating Children
Prozac has been cleared for treating children over eight years suffering from depression, but regulators have imposed strict conditions on its use//. The conditions imposed by the European licensing agency (EMEA) call for the use of the drug only when other therapies have failed. "Prozac should only be used together with psychological therapy in patients non-responding to such therapy...Sciton Receives FDA Clearance for Lipolysis and Wrinkle Treatment
Sciton announced that the new ProLipo(TM) laser module received clearance from the U.S. Food and Drug Administration for laser-assisted lipolysis, and its BBL(TM) broadband pulsed light received clearance for the treatment of wrinkles. ProLipo represents the latest technological advancement from Sciton to employ fiber-delivered laser energy to target fatty tissue. Using the ProLipo...