Australian-based artificial intelligence (AI) software developer Annalise.ai has secured clearances from the U.S. Food and Drug Administration (FDA) that cover additional indications for use of its CT and x-ray triage and notification software.
Annalise Triage uses deep learning to identify the suspected presence of time-sensitive pathologies and flag priority cases within the radiology worklist, assisting the care team in treating patients with the most critical conditions first.
New clearances for the company's Triage CT Brain algorithm include the following:
- Acute subdural/epidural hematoma
- Acute subarachnoid hemorrhage
- Intra-axial hemorrhage
- Intraventricular hemorrhage
In addition, clearances for the company's Triage Chest X-ray algorithm now include the following:
- Pneumothorax
- Tension pneumothorax
- Pleural effusion
- Pneumoperitoneum
- Vertebral compression fracture
The latest FDA clearances will allow the company to expand into the U.S. market and bring the total number of U.S.-available findings for its triage and notification products to nine, Annalise.ai representatives said.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
