New AI Software Facilitates Earlier Brain CT Detection and Triage of Obstructive Hydrocephalus

By MedImaging International staff writers
Posted on 14 Sep 2023

Image: The first ever radiology triage device has been awarded FDA Breakthrough Devices Designation (Photo courtesy of Annalise.ai)

Obstructive hydrocephalus (OHCP), a critical medical condition, occurs when cerebrospinal fluid builds up in the brain, causing a rapid increase in intracranial pressure that can become dangerous if not addressed promptly. Now, an AI-powered medical imaging solution has been designed for the triage and notification of OHCP on non-contrast brain CT scans.

Annalise.ai (Sydney, Australia) has obtained 510(k) FDA clearance for its AI-based system for the triage and notification of OHCP in non-contrast brain CT images. In addition, the company's software tool for OHCP has been granted the FDA's Breakthrough Device Designation, making it the first radiology triage tool to receive this recognition since the launch of the FDA Breakthrough Devices Program. This advanced technology from Annalise.ai features both passive and active alert mechanisms for potential OHCP cases detected in unenhanced head CT scans. This latest approval expands the company’s range of FDA-cleared products in the United States to ten FDA-cleared findings – five for chest X-rays (CXR) and five for head CT scans (CTB). This positions Annalise.ai as one of the most comprehensive providers of FDA-cleared AI-based triage solutions in the U.S.

“Our FDA clearances, including this latest addition, underscore our dedication to revolutionizing medical imaging,” said Lakshmi Gudapakkam, CEO of Annalise.ai. “Annalise.ai is proud to offer a comprehensive suite of AI solutions that significantly enhance diagnostic capabilities and assist in delivering prompt, life-saving interventions for conditions like obstructive hydrocephalus.”

“Our advanced algorithms support radiologists by facilitating prioritization of non-contrast head CT studies with suspected critical findings, thereby optimizing radiology workflow,” added Dr Rick Abramson, 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.”

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