The U.S. Food and Drug Administration (FDA) has cleared StrokeViewer LVO, NICO.LAB’s artificial intelligence powered solution in stroke care. StrokeViewer enables physicians to provide every stroke patient with the right treatment, as fast as possible. Two million brain cells die every minute until blood flow is restored (Saver, 2006), starting treatment earlier can make the difference between recovery or life-long disability.
This week the FDA approved a 510k application (FDA K200873) for StrokeViewer LVO, an artificial intelligence algorithm for fast triaging of stroke patients. StrokeViewer LVO detects image characteristics associated with a Large Vessel Occlusion (LVO) and alerts physicians. The FDA application was supported by a multi center clinical study where the performance of the algorithm was retrospectively evaluated in 384 patients from multiple US stroke centers. An expert panel assessed the data to identify LVOs (ICA, M1 and M2) and comparison with the algorithm showed results that exceeded the performance goal.
StrokeViewer was developed by the Dutch medtech company NICO.LAB. The cloud-based solution uses artificial intelligence to support physicians in the emergency stroke setting. The FDA-cleared LVO algorithm is embedded in a cloud-based system that sends a notification to the medical specialists involved just minutes after a stroke patient arrives in the hospital. The physicians are able to use their smartphones, in the hospital but also at home, to inspect the CT images in a web viewer and diagnose a stroke.
“Medical specialists are under enormous pressure to make fast decisions day and night, but it’s not easy. Complicated assessment and interhospital communication sadly make life difficult for physicians motivated to treat stroke victims effectively” – said Merel Boers, CEO and co-founder of NICO.LAB. “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.”
StrokeViewer is currently in use in Australia and Europe where it has proven to reduce the time from hospital arrival to start treatment for patients with acute stroke, leading to reduced patient disability in the short-term and more clot removal treatments performed.
Stroke is a leading cause for serious long-term disability in the United States. The economic burden of stroke exceeds an astonishing $100 billion per annum (Girotra, Lekoubou et al., 2020). Stroke incidence and associated costs are rising drastically due to an ageing population and increasing unhealthy lifestyle. NICO.LAB is dedicated to playing a crucial role in reducing these stroke related costs and improving quality of life of patients by combining human and artificial intelligence to revolutionize emergency stroke care.
StrokeViewer consists of a comprehensive set of tools to support the entire stroke workflow. StrokeViewer LVO is the first with FDA approval. Local availability of StrokeViewer functionality is subject to applicable CE marking, TGA and FDA approval (actual status on www.nico-lab.com).
Saver, 2006 – “Time is brain—quantified.” Stroke 37.1 (2006): 263-266
FDA K200873 – StrokeViewer LVO is approved as HALO under FDA submission number K200873
Girotra, Lekoubou et al. 2020 – “A contemporary and comprehensive analysis of the costs of stroke in the United States” Journal of Neurological Sciences, volume 410, 116643