RAPID CTA gets FDA clearance


iSchemaView has received final clearance from the US Food and Drug Administration (FDA) for RAPID CTA, the company’s 3D imaging solution for Computed Tomography Angiography. RAPID CTA is the newest addition to iSchemaView’s neuroimaging platform—including RAPID CTP and RAPID MRI—which is designed to provide physicians with fast, fully-automated, elegant and easy-to-interpret imaging that facilitates clinical decision making around cerebrovascular disease, such as stroke.

In simplest terms, CTA provides visualisation of blood vessels in the brain. Using an injectable contrast agent, high-tech X-ray imaging and sophisticated computer analysis, a CT angiogram provides physicians with detailed and accurate images of the vasculature. However, interpreting standard CTA output is a cumbersome time-consuming process.

According to a company release, RAPID CTA automatically provides clear, easy to interpret CTA maps which include a coloured overlay to identify brain regions with reduced blood vessel density. The severity of reduction can be readily visualised by a simple, four-colour-coded scale. Additionally, a 3D reconstruction of the vasculature allows physicians to rotate the image for optimal viewing of the vessels from multiple angles. All of this in a few minutes. RAPID CTA is a tool for all doctors involved in neurovascular emergencies–from the ER doctor making decisions about patient transfer to the neurointerventionalist getting ready for an incoming thrombectomy procedure.

“Our goal is to provide healthcare professionals around the world with the most comprehensive and intuitive suite of imaging solutions possible,” said Don Listwin, CEO of iSchemaView. “With new FDA clearance and the release of RAPID CTA, we are making good on that goal. 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 is all about offering them the right imaging solution choice, for the right patient at the right time.”

In an effort to save valuable diagnosis and treatment 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.

RAPID CTA maps provide an intuitive and easy to interpret view of the brain vessels, helping physicians with:
Clinical decision making
Patient triage
Collaboration between community hospitals and specialists
Appropriate patient transfers to specialty centres

“Many eligible stroke patients with large vessel occlusions must be quickly transferred to a comprehensive stroke centre. The new automated RAPID CTA tool makes it easy for community hospitals to quickly identify potential candidates for treatment and for experts at the comprehensive centres to verify that the patient is appropriate for transfer,” says Greg Albers, professor of Neurology at Stanford University, director of the Stanford Stroke Center and cofounder of iSchemaView. “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. That’s powerful.”


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