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GE and Picker get nods for diffusion MRI
GE Medical Systems of Milwaukee and Picker International of Cleveland have received 510(k) clearances from the Food and Drug Administration for their respective diffusion-weighted packages for MRI scanning. Diffusion-weighted MRI is useful for early
GE Medical Systems of Milwaukee and Picker International of Cleveland have received 510(k) clearances from the Food and Drug Administration for their respective diffusion-weighted packages for MRI scanning. Diffusion-weighted MRI is useful for early detection of stroke, and for differentiating between acute and chronic brain infarct.
GE's offering is called EchoPlus and is for the Signa Horizon and Signa Horizon LX high-field MRI scanners. EchoPlus uses single-shot diffusion-weighted echo-planar imaging (EPI) techniques to acquire up to 150 brain images in less than a minute.
Picker's package, which has yet to receive a product name, will be offered as an option for users of the company's new Eclipse and Polaris high-field scanners. Picker received 510(k) clearance on Feb. 6 to sell the package.
The package will also be offered to users of Edge and Vista, Picker's older MRI systems, that have received the company's Accelerator computer upgrade, according to Linda Eastwood, MR marketing manager. Picker has several diffusion-weighted MRI packages installed at beta sites, and will begin production shipments in the next several months, Eastwood said.
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