GE Healthcare wins FDA 510(k) for Signa Premier MRI

GE Healthcare (NYSE:GE) said today it won FDA 510(k) clearance for its Signa Premier wide bore 3.0 Tesla magnetic resonance imaging system.

The company said the Signa Premier was the result of a 4-year collaboration with the National Football League and research institutions worldwide and integrated technology to aid in the detection of biomarkers for the potential diagnosis of mild traumatic brain injury.

The newly cleared Signa Premier system features GE Healthcare’s newest short-bore, high-homogeneity 3.0T superconductive magnet, as well as the most most powerful gradient system the company has developed for a wide bore 3.0T.

The system also includes digital RF transmit and receive architecture, providing 146 independent receiver channels to allow for simultaneous acquisition of patient data from multiple high channel-density surface coils, the company said.

The Signa is powered by a SuperG gradient coil, which the company claims provides “outstanding performance and superb stability,” GE Healthcare said

“We are thrilled to bring SIGNA Premier to clinicians. We believe that its advanced applications and breakthrough innovations will deliver research-focused clinical capabilities and wide-bore patient comfort. This new system will help clinicians push the boundaries of what’s possible with MR,” GE Healthcare MRI prez & CEO Eric Stahre said in a press release.

Late last month, GE Healthcare posted 2nd quarter earnings with sales and profit growth that were sorely needed bright spots for its parent company, which saw its overall profits halved on a nearly -12% top-line slide but still managed to eke out revenue and earnings beats.

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