Cerebrovascular Imaging Device RAPID CTA Gets FDA Nod


The Computed Tomography Angiography device from iSchemaView gives physicians quick, and diverse, options to analyze stroke patient candidates.

The US Food and Drug Administration (FDA) has announced the approval of a three-dimensional imaging solution for Computed Tomography Angiography (RAPID CTA).

The solution, from cerebrovascular imaging analysis company iSchemaView, joins the company’s brand of fully-automated imaging devices such as RAPID CTP and RAPID MRI to facilitate clinical decision-making for cerebrovascular diseases including stroke.

The CTA provides physicians with a visualizations of blood vessels in the brain, via an injectable contrast agent, X-ray imaging and computer analysis. According to iSchemaView, it improves on what’s currently a “cumbersome time-consuming process” to retrieve standard CTA output.

“Our goal is to provide healthcare professionals around the world with the most comprehensive and intuitive suite of imaging solutions possible,” Don Listwin, CEO of iSchemaView, said in a statement. “With new FDA clearance and the release of RAPID CTA, we are making good on that goal.”

The RAPID CTA provides clear maps with colored overlay that identifies brain regions with reduced blood vessel density. Reduction severity of blood vessels can be visualized through a four-color-coded scale, and physicians can view a 3D reconstruction of vasculature that can be rotated and analyzed from various angles.

The device is also intended as a telehealth-friendly tool: it will offer remote viewing for physicians away from patients, with image maps becoming immediately available for physician review on any desktop or mobile device.

Gregory W. Albers, MD, professor of Neurology, Stanford University, Director of the Stanford Stroke Center, and cofounder of iSchemaView, said many stroke patients with large vessel occlusions have to be transferred quickly to a comprehensive stroke center. The automated tool will ease the burden of community hospitals trying to quickly identify stroke patient candidates for treatment.

“With the addition of CTA to RAPID’s FDA indications, hospitals and clinics of all sizes and locations can now use the platform to immediately review images from wherever they are,” Albers said. “That’s powerful.”

To Listwin, the device, and the company’s accompanying platform, is a circumstantial benefit in most health care practices.

“We ensure physicians can take advantage of RAPID’s power whether they choose plain CT, CT Angiography, CT Perfusion or MR diffusion and perfusion,” Listwin said. “It’s all about offering them the right imaging solution choice, for the right patient at the right time.”

For neurologists working in stroke care, MD Magazine's new sister site, NeurologyLive, serves as a resource for extensive clinical news, articles, videos, and newly released data and research.

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