Nicolab has announced that its computed tomography (CT) perfusion algorithm, which is integrated into the company’s StrokeViewer platform, has obtained 510(k) clearance from the US Food and Drug Administration (FDA). Nicolab’s StrokeViewer solution is also set to be deployed across 58 hospitals at the US Department of Veterans Affairs (VA) in early 2024.
This marks “a significant milestone” in Nicolab’s mission to enhance stroke care in the USA, as stated in a press release. The same release notes that the CT perfusion regulatory achievement complements the company’s prior clearances for the algorithm, including European CE-mark and Australian Therapeutic Goods Administration (TGA) approvals.
Nicolab chief executive officer Michael Macilquham—whose appointment was announced recently, on 8 November 2023—emphasised the “transformative impact” of perfusion software in stroke management, owing to the fact it can help physicians make informed clinical decisions with confidence.
Additionally, he stated, the integration of the CT perfusion algorithm into the StrokeViewer workflow solution enables “seamless image sharing, collaboration, and communication”, among stroke healthcare teams, creating the potential to speed up the time to treatment for stroke patients. Macilquham also reaffirmed Nicolab’s dedication to the US market, noting the “indispensable role” of the StrokeViewer product for acute care teams as well as the company’s commitment to enhancing patient outcomes.
