FDA clears device that enables 3D mapping of vessels in brain

A device that is able to provide three-dimensional “maps” of blood vessels in the brain has received final clearance from the Food and Drug Administration.

The agency’s decision will allow iSchemaView, Redwood City, Calif.-based to sell its 3D imaging solution for computed tomography angiography.

Called Rapid CTA, the device can provide visualization of blood vessels in the brain. Images are created by using an injectable contrast agent, technologically advanced X-ray imaging and sophisticated computer analysis. CT angiograms give physicians detailed and accurate images of vessels in the brain, but the new device is intended to help physicians interpret standard CTA output.

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The device can provide clear, easy-to-interpret CTA maps, which include colored overlays to identify brain regions with reduced blood vessel density—the severity of reduction can be visualized through a scale coded with four colors. Also, a 3D reconstruction of the vasculature enables physicians to rotate the image for optimal viewing of the vessels from multiple angles.

“Our goal is to provide healthcare professionals around the world with the most comprehensive and intuitive suite of imaging solutions possible,” says Don Listwin, CEO of iSchemaView. “With new FDA clearance and the release of Rapid CTA, we ensure physicians can take advantage of RAPID’s power, whether they choose plain CT, CT Angiography, CT Perfusion or MR diffusion and perfusion. It’s all about offering them the right imaging solution choice, for the right patient at the right time.”

Rapid CTA also offers remote viewing for physicians in the hospital, at home or on the road. Image maps are immediately available to doctors for review on any desktop or mobile device. Enabling quick diagnosis is important for patients with large vessel occlusions, who must be quickly transferred from low-intensity settings to receive specialized treatment.

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