FDA Clears Adjunctive AI Software for Acute Infarct Triage with Non-Contrast CT
The Harrison.ai software is reportedly the first AI software to gain clearance for acute infarct triage on non-contrast CT scans.
The Food and Drug Administration (FDA) has granted 510(k) clearance to Harrison.ai’s artificial intelligence (AI) software for acute infarct triage with non-contrast computed tomography (CT) scans.
Harrison.ai said the software goes beyond vessel occlusion detection, facilitating triage for brain tissue injury in the anterior, middle and posterior cerebral arteries as well as cerebellar, basilar and watershed infarcts. The company added that the Harrison.ai software is the
The AI software offers up to an 89.2 percent sensitivity for acute infarct on thin slice non-contrast CT and 85.7 percent sensitivity for thick slice non-contrast CT, according to Harrison.ai.
“Acute infarct on non-contrast CT is one of the hardest findings in radiology. Most radiologists will welcome the help in bringing these cases to the front of the queue. That's why we felt it was important to build it.,” said Jarrel Seah, M.D., a neuroradiologist and chief medical officer at Harrison.ai.
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