NICO.LAB receives FDA clearance for AI stroke care solution 


NICO.LAB has received clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI) powered solution in stroke care, StrokeViewer LVO. 

According to NICO.LAB, StrokeViewer LVO is an AI algorithm for fast triaging of stroke patients. The company claims that StrokeViewer LVO detects the image characteristics of Large Vessel Occlusion (LVO) and alerts physicians. 

The FDA approved the 510k application supported by a multi-centre clinical study where the performance of the StrokeViewer algorithm was retrospectively evaluated on CT images from 384 patients from multiple USA stroke centres. The results from the algorithm were then compared with the results from a panel of experts who also assessed the data to identify the LVOs. According to NICO.LAB’s press release, the algorithm exceeded the set performance goal. 

Merel Boers, CEO and co-founder of NICO.LAB, commented on their FDA clearance, “Medical specialists are under enormous pressure to make fast decisions day and night, but it’s not easy. Complicated assessment and inter-hospital communication sadly make life difficult for physicians motivated to treat stroke victims effectively,” she continued, “With our first FDA clearance we are now able to show U.S. physicians how impactful the combination of human and artificial intelligence is. And yes, more will follow as we are fully committed to unlocking the full healthcare potential for every patient.”

NICO.LAB is a Dutch company founded in 2015, from the Amsterdam University Medical Center in the Netherlands. Their StrokeView solution is already in use in Europe and Australia, where they claim it has already been proven to reduce the time from hospital arrival to start of treatment for patients with acute stroke.


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