Neurognostics Inc. announced this week that the FDA has granted it Special 510(k) approval for market clearance the company's MindState fDAD. The original FDA clearance for the system earlier this year was classified for a fMRI (functional Magnetic Resonance Imaging) data acquisition device. However, this special clearance 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, according to Neurognostics.
The MindState fDPD includes a library of ready-to-use stimulation paradigms designed to work optimally with the Neurognostics fDAD fMRI data collection system. Each paradigm is designed to stimulate a specific cognitive, executive, memory, motor, or other brain function. Healthcare professionals can use these paradigms for a variety of clinical applications, including presurgical mapping of the brain, and neurological assessment of their patients. Each paradigm includes specific imaging protocols for optimal MR data collection, the company said.