FDA clears AI triage tool that detects acute infarcts on noncontrast CT scans
A tool that targets a difficult-to-detect neurological finding on noncontrast brain CT scans has just been cleared by the U.S. Food and Drug Administration.
Harrison.ai announced the clearance of its acute infarct triage tool March 5; this latest clearance is one of many for the company. Unlike other stroke detection applications, the model covers six vascular territories and mechanisms of infarct. Beyond vessel occlusions, it also assesses tissue injury in anterior/middle/posterior cerebral artery, cerebellar, basilar and watershed infarcts. The company believes this offering could help detect signs of stroke earlier, leading to expedited diagnosis and management.
"Acute infarct on noncontrast 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," Jarrel Seah, MD, chief medical officer at Harrison.ai and practicing radiologist, said in a statement. "That's why we felt it was important to build it."
Prior research on the infarct detection algorithm revealed it capable of achieving 89.2% sensitivity on thin slices and 85.7% on thick slices. What’s more, it yields more than than 80% sensitivity and specificity on multiple operating points for both slice thicknesses. It was validated against confirmed infarcts that were not previously detected on noncontrasted imaging.
Harrison.ai maintains that recent comparisons of their tool against other FDA-cleared algorithms proved its performance outweighs others in both sensitivity and specificity. Those figures were based on its performance evaluating noncontrasted imaging against computed tomogaphy angiography exams.
This latest clearance marks Harrison.ai’s eighth to target CT brain findings and its 13th total.
"Patients who aren't on a dedicated stroke protocol may experience significant delays before acute infarct is identified. When time is brain, that has real patient impact," added Aengus Tran, MD, CEO and co-founder of Harrison.ai.
Learn more about the company’s latest regulatory clearance here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.