RapidAI snags FDA clearance for neuroimaging analysis device

It uses machine learning to help physicians detect brain injuries and decide if a patient is eligible for a thrombectomy.
By Mallory Hackett
02:15 pm

RapidAI, a health tech company specializing in stroke imaging, has received clearance from the FDA for its Rapid ASPECTS neuroimaging analysis device.

The product was designed to improve physicians’ interpretations of Non-Contrast CT (NCCT) scans using the automated ASPECT score, according to the company. It uses the Alberta Stroke Program Early CT Scoring (ASPECTS) and machine learning to come up with an ASPECTS score for certain regions of the brain that have early signs of brain infarction.

With the information provided by Rapid ASPECTS, physicians can identify the areas of the brain that have irreversible injuries and decide if a patient is eligible for a thrombectomy, the company said.

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Developers used data from over 650,000 scans from more than 1,500 hospitals all over the world to create the device.

It got cleared in the 510(k) Computer-Assisted Diagnostic software category. Rapid AI said it will be available commercially in the U.S. later this month.


Every year, about 795,000 people in the U.S. have a stroke, according to the Centers for Disease Control and Prevention. That breaks down to someone having a stroke every 40 seconds.

Of those Americans who experience a stroke, 140,000 die each year.

The majority of strokes are ischemic, or caused by blockages that prevent blood from getting to the brain, the CDC says.

A study published by the National Center for Biotechnology Information concluded that thrombectomies are an effective method for treating ischemic strokes.

With faster and more accurate detection of infarctions, more patients may be able to get treated for their ischemic strokes.


Last month RapidAI released a new analytics platform called RapidAI Insights. It was created to help hospitals make decisions with access to treatment and outcome data that are collected and displayed on the platform.

Another company that uses AI to improve care for stroke patients is Viz.ai. It raised $50 million last year for its system, which triages stroke patients and coordinates care.


“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, the cofounder of RapidAI, in a statement. “In addition to helping stroke teams with faster triage and transfer decisions, Rapid ASPECTS also improves the accuracy of typical readers.”



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