Rapid ASPECTS receives CADx clearance from the FDA


Rapid ASPECTS receives CADx clearance from the FDARapidAI has announced that Rapid ASPECTS has received US 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 scans using a standardised 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 non-contrast CT scans—helping physicians identify areas of irreversible brain injury.

The company state that by automating and standardising 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 Gregory Albers of Stanford University (Stanford, USA), 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.”

The press release goes on to list three key advantages of the technology. In addition to Rapid ASPECTS automatically delivering a standardised ASPECT score, in turn assisting physicians’ decisions, it utilises a machine-learning algorithm that has been validated in clinical research studies. While the algorithm delivers fast measurements, RapidAI write that the system also supports collaboration between hospitals and specialists, increasing the speed of triage and transfer decisions of patients.

 “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.”

Currently, RapidAI 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.


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