FDA grants 510(k) clearances to triage, notification findings on chest, head imaging

The FDA has granted 510(k) clearances to seven triage and notification findings of varying conditions on chest X-ray and head CT images, according to a manufacturer-issued press release.

According to the release, Annalise.ai employs artificial intelligence (AI)-assisted triage and notification solutions to detect time-sensitive pathologies on images and bring attention to conditions that need to be addressed as soon as possible.

Each of the seven findings have demonstrated advanced detection accuracy, diagnostic decision-making and reporting speed in clinical studies, the release said.

In terms of chest X-rays, Annalise.ai now has FDA-cleared tools for identifying pleural effusion, pneumoperitoneum and vertebral compression fracture. This is an addition to the company’s previous FDA-cleared triage and notification for pneumothorax and tension pneumothorax, according to the release.

For head CT imaging, the FDA clearance includes triage and notification findings for acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage and intraventricular hemorrhage.

According to the release, patients can get diagnosed more quickly and make the best choice for treatment when the outlined conditions are detected sooner rather than later.

“AI-assisted triage is becoming increasingly important in health care,” Rick Abramson, MD, MHCDS, FACR, chief medical officer of Annalise.ai, said in the release. “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 pandemic.”