On November 20th the FDA cleared NICO.LAB’s radiological computer aided triage and notification software for stroke patients to be marketed in the United States.
“After the successful introduction of StrokeViewer in Europe last year, this is great news for stroke patients in the US as well”, says Claus Schaffrath, Managing Director of MD squared.
“We are proud to have successfully supported NICO.LAB to get one of the first artificial intelligence algorithms over the finish line with the FDA. As time is brain in stroke treatment StrokeViewer’s detection of image characteristics associated with large vessel occlusions will enable physicians to be alerted quicker and initiate the right intervention for patients with an acute stroke as fast as possible.”
“For entering the US market we were aware that the clearance of our artificial intelligence software would charter fairly novel territory”, says Merel Boers, CEO of NICO.LAB. ”, so tapping into MD squared’s regulatory expertise in our dialogue with the FDA was very valuable. Now we are able to show also to U.S. physicians how impactful the combination of human and artificial intelligence in the management of acute stroke can be. For us, this is just the beginning of employing artificial intelligence to unlocking the full healthcare potential for every patient.“
More information on NICO.LAB’s FDA clearance can be found HERE