FDA grants 510(k) clearance, breakthrough designation for hydrocephalus diagnostics

The FDA has granted 510(k) clearance to a radiology artificial intelligence firm for triage and notification of obstructive hydrocephalus on non-contrast brain CT scans, according to a release.

The FDA also granted breakthrough device designation for an obstructive hydrocephalus software tool, according to the release from Annalise.ai.

The clearance marks the first time a radiology triage was granted breakthrough status since the inception of the FDA’s Breakthrough Devices Program, which identifies medical devices that improve treatment or diagnosis of life-threatening or debilitating conditions, while seeking to provide quicker access to these devices for health care providers, per the release.

Annalise.ai’s technology allows for both passive and active notifications for suspected OHCP cases identified on unenhanced head CT scans, the company stated. Obstructive hydrocephalus is a potentially life-threatening condition where cerebrospinal fluid settles in the cranial vault, leading to elevated intracranial pressure that can escalate rapidly if left untreated.

“Our advanced algorithms support radiologists by facilitating prioritization of non-contrast head CT studies with suspected critical findings, thereby optimizing radiology workflow,” Annalise.ai Chief Medical Officer Rick Abramson, MD, MHCDS, FACR, said in the release. “With its set of clearances, Annalise.ai promotes faster report turnaround times by identifying and elevating critical cases for immediate attention.”