December 19, 2023
Amsterdam, Netherlands – Nicolab, a distinguished pioneer in stroke workflow technology, is proud to announce that its CT Perfusion algorithm, which is integrated into the StrokeViewer® platform, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA). This marks a significant milestone in the company’s mission to enhance stroke care in the United States.
The CT Perfusion regulatory achievement complements the company’s prior clearances for the algorithm, including CE and TGA approvals, and showcases Nicolab’s commitment to delivering innovative solutions that uphold high standards of safety and efficacy across the globe.
Nicolab’s CEO, Michael Macilquham, emphasized the transformative impact of Perfusion software in stroke management, as it can help physicians make informed clinical decisions with confidence. Additionally, the integration of the CT Perfusion algorithm into the StrokeViewer® workflow solution enables seamless image sharing, collaboration, and communication among stroke healthcare teams, allowing the potential to speed up the time to treatment for stroke patients.
Moreover, Macilquham reaffirmed Nicolab’s dedication to the U.S. market, noting the indispensable role of the StrokeViewer® product for acute care teams and the company’s commitment to enhancing patient outcomes.
Nicolab’s StrokeViewer® solution will be deployed across 58 hospitals at the prestigious US Department of Veterans Affairs early in 2024.
For further information about Nicolab and its sophisticated stroke workflow solutions, please visit nicolab.com.
Nicolab’s groundbreaking technology enables fast and accurate image analysis that helps physicians in making well-informed decisions. Nicolab developed StrokeViewer® to support the complex process of clinical decision-making in an environment where every minute counts.
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