Indicated for the triage and notification of obstructive hydrocephalus on non-contrast brain computed tomography (CT), the artificial intelligence (AI)-enabled software is reportedly the first radiology triage modality to obtain the Food and Drug Administration’s (FDA) Breakthrough Device Designation.
The Food and Drug Administration (FDA) has granted 510(k) clearance for a new artificial intelligence (AI) software that may facilitate earlier brain CT detection and triage of the potentially life-threatening condition of obstructive hydrocephalus (OHCP).
Based on assessment of non-contrast brain CT scans, the AI software provides passive and active notifications on suspected cases of OHCP, according to Annalise.ai, the developer of the software. The company noted that the OHCP software is the first triage device in radiology to receive the FDA’s Breakthrough Device Designation.
The FDA clearance of the OHCP software is the 10th FDA clearance for the company’s AI-powered software applications, including five software applications that can be utilized for head CT scans, according to Annalise.ai.
“Our advanced algorithms support radiologists by facilitating prioritization of non-contrast head CT studies with suspected critical findings, thereby optimizing radiology workflow,” noted Rick Abramson, the chief medical officer at Annalise.ai. “With its set of clearances, Annalise.ai promotes faster report turnaround times by identifying and elevating critical cases for immediate attention.”