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Annalise.ai Obtains Seven New AI FDA 510(k) Clearances for Head CT and Chest X-Ray


The artificial intelligence (AI) triage and notification indications include acute subdural/epidural hematoma and acute subarachnoid hemorrhage for head computed tomography (CT) imaging.

The Food and Drug Administration (FDA) has reportedly granted a total of seven new 510(k) clearances for the use of the artificial intelligence (AI)-assisted triage modalities Annalise Triage Head CT and Annalise Triage CXR.

The new computed tomography (CT) indications for Annalise Triage Head CT include acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage, and intraventricular hemorrhage, according to Annalise.ai, the manufacturer of Annalise Triage Head CT and Annalise Triage CXR.

The company said additional FDA clearances have increased the AI-assisted triage indications to five for Annalise Triage CXR, including detection of pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fracture.

Annalise.ai said the modalities utilize deep learning technology to help detect suspected pathologies and flag cases that warrant elevated priority on radiology worklists.

“AI-assisted triage is becoming increasingly important in healthcare,” noted Rick Abramson, M.D., MHCDS, FACR, the chief medical officer for Annalise.ai. “Triage solutions drive quality improvement by enabling earlier detection and intervention for our most critically ill patients. And by prioritizing the radiology worklist, these solutions also help address some of the burnout issues that have affected our specialty since the (COVID-19) pandemic.”

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