27 Oct Neurognostics receives special FDA clearance for MindState fDAD
Milwaukee, Wis. — Neurognostics, Inc., 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 February 2005 as an fMRI data acquisition device. The Special 510(k) allows Neurognostics to enhance fDAD by providing a library of stimulation paradigms, data collection protocols and image processing services, collectively known as MindState fDPD, and marketing it for clinical use. With this clearance, the company will be able to provide off-site fMRI data processing services to its customers.
Founded in 2003, Neurognostics, Inc. develops clinical applications for fMRI.