FDA Approves First AI-Powered Stroke Imaging Solution

July 7, 2020

Rapid ASPECTS receives clearance as first neuroimaging analysis device in computer-aided diagnostic category.

Advanced stroke imaging company RapidAI announced today it has secured 510(k) clearance from the U.S. Food & Drug Administration for its neuroimaging analysis device Rapid ASPECTS.

This is the first device to receive clearance in the computer-aided diagnostic software (CADx) category, and, according to a company statement, it is the only product confirmed to improve physician interpretations of non-contract CT using a standardized APSECT score. It can be particularly useful for less experienced readers, company officials said.

“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.”

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Rapid ASPECTS is based on the Alberta Stroke Program Early CT Scoring (ASPECTS) system, and it uses a validated machine-learning algorithm to identify affected regions of the brain and create an ASPECT score than can pinpoint early signs of stroke in non-contrast CT scans. In doing so, it can help providers identify areas of the brain that have irreversible injury.

Overall, according to company information, Rapid ASPECTS offers three main features:

  • Standardized, rapid assessment within a few minutes to help physicians determine a patient’s eligibility for thrombectomy
  • Fast measurements via machine-learning algorithm validated by clinical research studies
  • Collaboration between facilities and specialists for faster triage and transfer decision

Ultimately, company officials said, Rapid ASPECTS is designed to 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 RapidAI co-founder Greg Albers, M.D., professor of neurology at Stanford University and director of the Stanford Stroke Center. “In addition to helping stroke teams with faster triage and transfer decision, Rapid ASPECTS also improves the accuracy of typical readers.”

Rapid ASPECTS is already available internationally and will be commercially available in the United States later in July.