The U.S. Food and Drug Administration has granted 510(k) clearance and breakthrough device designation for a radiology triage tool from Annalise.ai, the company announced Wednesday.
The Sydney, Australia-based vendor said its solution enables both passive and active notifications for suspected obstructive hydrocephalus, or excessive accumulation of cerebrospinal fluid in the skull, on noncontrast CT scans.
Annalise.ai believes this is the first radiology triage device to earn breakthrough status from the FDA program, meant to grant quick access to devices that diagnose or treat debilitating conditions. This marks the 10th FDA OK in the AI firm’s portfolio, which includes five for chest X-ray and the other half for CT.
“Our FDA clearances, including this latest addition, underscore our dedication to revolutionizing medical imaging,” “Lakshmi Gudapakkam, CEO of Annalise.ai, said in a Sept. 13 announcement.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.