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.
![Images show the pectoralis muscles of a healthy male individual who never smoked (age, 66 years; height, 178 cm; body mass index [BMI, calculated as weight in kilograms divided by height in meters squared], 28.4; number of cigarette pack-years, 0; forced expiratory volume in 1 second [FEV1], 97.6% predicted; FEV1: forced vital capacity [FVC] ratio, 0.71; pectoralis muscle area [PMA], 59.4 cm2; pectoralis muscle volume [PMV], 764 cm3) and a male individual with a smoking history and chronic obstructive pulmonary disorder (COPD) (age, 66 years; height, 178 cm; BMI, 27.5; number of cigarette pack-years, 43.2, FEV1, 48% predicted; FEV1:FVC, 0.56; PMA, 35 cm2; PMV, 480.8 cm3) from the Canadian Cohort Obstructive Lung Disease (i.e., CanCOLD) study. The CT image is shown in the axial plane. The PMV is automatically extracted using the developed deep learning model and overlayed onto the lungs for visual clarity.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/03/genkin.25LqljVF0y.jpg?auto=format%2Ccompress&crop=focalpoint&dpr=2&fit=crop&h=167&q=70&w=250)
