Rapid ASPECTS is first ever neuroimaging solution to receive CADx clearance from FDA

RapidAI, the worldwide leader in advanced imaging for stroke, today announced that Rapid ASPECTS has received Food and Drug Administration (FDA) clearance as the first neuroimaging analysis device in the CADx (Computer-Assisted Diagnostic software) category. Rapid ASPECTS is the only neuroimaging product shown to improve physicians’ interpretations of Non-Contrast CT (NCCT) scans using a standardized ASPECT score. Validated through the rigorous FDA process, the use of Rapid ASPECTS automated score combined with the physician’s review of the scan, improves the accuracy of the ASPECT score calculation which is particularly important for less experienced readers.

Based on the Alberta Stroke Program Early CT Scoring (ASPECTS) system, Rapid ASPECTS uses a validated machine-learning algorithm to automatically identify the ASPECTS regions of the brain and generate an ASPECT score to indicate early signs of brain infarction on NCCT scans—helping physicians identify areas of irreversible brain injury.

By automating and standardizing this process, Rapid ASPECTS helps stroke teams across hospital sites and referral networks quickly assess patient eligibility for thrombectomy—enabling faster triage and transfer decisions that facilitate better patient outcomes.

“Rapid ASPECTS represents the next AI-powered step forward in stroke imaging, and the groundbreaking CADx clearance from the FDA puts it in a class by itself,” said Dr. Greg Albers, Professor of Neurology at Stanford University, Director of the Stanford Stroke Center and cofounder of RapidAI. “In addition to helping stroke teams with faster triage and transfer decisions, Rapid ASPECTS also improves the accuracy of typical readers.”

Rapid ASPECTS Provides

Standardized, predictive assessment: In a few minutes, Rapid ASPECTS automatically delivers a standardized ASPECT score—assisting physicians to quickly identify areas of irreversible injury and help determine a patient’s eligibility for thrombectomy.

Validated Machine-Learning Intelligence: Rapid ASPECTS delivers fast measurements utilizing a sophisticated, machine-learning algorithm that has been validated in clinical research studies.

Faster Triage or Transfer Decisions: Rapid ASPECTS supports collaboration between hospitals and specialists to make faster triage and transfer decisions for patients—helping to facilitate better patient care and outcomes.

“The FDA’s advanced CADx clearance has never been granted to a neuroimaging solution before,” said Jim Rosa, Senior Vice President of Regulatory and Clinical at RapidAI. “Through a combination of clinically validated advances in AI and machine learning, Rapid ASPECTS offers a glimpse into the future of stroke imaging.”

RapidAI is the most-widely used stroke imaging software for patient care, research, and clinical trials—helping hospitals around the world save time, money, and lives. It is the only clinically validated platform available and the gold standard for advanced cerebrovascular imaging.

Based on intelligence gained from over 650,000+ scans from more than 1,500 hospitals in over 50 countries, the artificial intelligence-based Rapid® platform creates high-quality, advanced images from non-contrast CT, CT angiography, CT perfusion, and MRI diffusion and perfusion scans. The platform offers an end-to-end portfolio of advanced cerebrovascular imaging analysis products—including Rapid ICH, Rapid ASPECTS, Rapid CTA, Rapid CTP, and Rapid MRI. –NSMedical