AI Software Device to Aid Clinical Assessment of CT Brain Findings Cleared by FDA

Annalise.ai, a company which develops artificial intelligence (AI) applications for use with medical imaging, announced that it had received additional clearances by the Food and Drug Administration (FDA) for its computer-aided triage and notification devices (CADt). These clearances were for CT brain findings for the following conditions:

• Acute subdural/epidural hematoma
• Acute subarachnoid hemorrhage
• Intra-axial hemorrhage
• Intraventricular hemorrhage

Additional clearances were received by the company for use in chest radiographs with findings of suspected pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fracture. According to details provided by the FDA, “CADt are software devices intended to aid in prioritization and triage of time-sensitive suspected findings based on the analysis of radiologic exams.” These software devices rely on deep learning to identify and flag potential pathologies within radiologic images. The FDA cautions that such devices are to be used to flag specific radiologic images and are not a substitute for physician review and interpretation of such images. CADt are not diagnostic devices but rather prioritization and triage tools.

"We are thrilled to mark our entry into the US neuroimaging space with this set of high-precision tools for prioritizing intracranial hemorrhage cases on non-contrast head CT," said Lakshmi Gudapakkam, CEO of Annalise.ai.