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Home » FDA clears RapidAI blood clot detector

FDA clears RapidAI blood clot detector

August 13, 2020 By Sean Whooley

RapidAI announced today that it received FDA clearance for its Rapid LVO system for detecting suspected large vessel occlusions (LVOs).

Menlo Park, Calif.-based RapidAI’s Rapid LVO is designed to help physicians speed up triage or transfer decision making. The system uses a vessel tracker, along with an assessment of brain regions with reduced blood vessel density to identify suspected LVOs in as few as three minutes before immediately notifying stroke team members, according to a news release.

According to the company, which touts the system as the “gold standard” of cerebrovascular imaging, Rapid LVO can identify suspected LVOs with a sensitivity of 97%, as well as a specificity of 96%.

“LVOs are the most disabling and deadly ischemic strokes,” Stanford University professor of neurology, director of the Stanford Stroke Center & RapidAI co-founder Dr. Greg Albers said in the release. “The ability to identify LVOs rapidly facilitates more effective treatment. This is why we are very excited about the FDA clearance of Rapid LVO, a significant step forward in stroke diagnostics and care.”

Filed Under: 510(k), Food & Drug Administration (FDA), Imaging, Neurological, Patient Monitoring, Regulatory/Compliance Tagged With: RapidAI

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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