Viz.ai Gets 510(k) Clearance for Subdural Hematoma Software

Viz.ai received 510(k) clearance from the FDA for its Viz SDH (subdural hematoma) artificial intelligence software for detection of hemorrhages between the skull and the surface of the brain.

The image analysis software can identify and differentiate between acute and chronic subdural hemorrhages. The tool helps users to decide whether immediate intervention is necessary.

The clearance was supported by data from a multicenter trial of more than 500 patients. The software achieved a high degree of accuracy with 94 percent sensitivity and 92 percent specificity, the company said.

The Viz SDH module is “very sensitive and specific, significantly increasing the number of subdural hemorrhages detected,” said Jayme Strauss, the company’s chief clinical officer.