RapidAI secures US FDA clearance for perfusion imaging tool within angio suite

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RapidAI has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its AngioFlow by RapidAI solution. As per a company press release, this module delivers perfusion imaging analysis directly within the interventional suite to promote greater clinical confidence, workflow efficiency, and potentially improve patient outcomes.

“AngioFlow by RapidAI will allow physicians to assess the need for additional imaging immediately in the interventional suite. By avoiding unnecessary scans, stroke patients can receive the timely care that can be the difference between being able to walk out of a hospital to their homes versus being discharged to a skilled nursing facility,” said Abhishek Singh (Creighton University School of Medicine, Omaha, USA).

Used by care teams working in the interventional suite, AngioFlow by RapidAI draws on validated deep clinical artificial intelligence (AI) to deliver clear, easy-to-interpret qualitative perfusion maps within minutes. The company’s recent release adds that the technology helps specialists assess ischaemic change in brain regions with reduced cerebral blood flow.

According to the company, AngioFlow by RapidAI enhances operational efficiency and financial value by reducing redundant imaging, and potentially saving time in patient care. Imaging at a referring facility allows physicians to evaluate the need for further scans in the interventional suite, accelerating clinical decisions and reducing unnecessary imaging—something the release notes is especially important in rural facilities and large hospital networks, where transfers from one facility to the next may take hours.

“We are pleased to expand our stroke AI imaging portfolio, the broadest in the industry, to include this new module. With AngioFlow by RapidAI, we can now support stroke AI imaging along the entire patient pathway, from the initial non-contrast CT [computed tomography] scan all the way to the interventional suite. Already registered and used in Japan and Europe, we believe this technology will make a significant difference in the lives of US stroke patients,” said Karim Karti, chief executive officer of RapidAI.


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