GE Healthcare receives FDA clearance for SIGNA™ Premier MRI scanner

GE Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration to sell its new wide bore 3.0T magnetic resonance imaging (MRI) system in the United States. SIGNA Premier is the result of a four-year collaboration with the National Football League and research institutions around the world to design new imaging tools to aid researchers in the detection of biomarkers for the potential diagnosis of mild traumatic brain injury.

The features of SIGNA Premier includes GE Healthcare’s latest, short-bore, high-homogeneity 3.0T superconductive magnet, the most powerful gradient system the company has developed for a wide bore 3.0T system. Its SuperG gradient coil is designed to delivery the performance of an ultra-high-performance, research class 60 centimeter MRI system in a 70 centimeter bore.

RF technology provides 146 independent receiver channels that allow the simultaneous acquisition of patient data from multiple high channel-density surface coils for faster scanning, higher image quality, and overall enhanced clinical performance as compared to previous generation GE MRI systems.

GE Healthcare states that a fit-adaptable design of the 48-channel head coil addresses 99.99% of the population, including patients with extremely large heads and short necks, while preserving high signal-to-noise ratio and outstanding image quality. SIGNA Premier can perform a routine fast brain examination in under five minutes by leveraging HyperSense, a new speed scanning tool.