FDA Approves Heuron’s Intracranial Hemorrhage AI

The US Food and Drug Administration (FDA) has cleared Heuron’s ICH stroke reporting system and classification software.

The Heuron ICH AI is designed to detect and identify cases of intracranial hemorrhage on non-contrast CT images. According to Heuron, clinical trials for the software were conducted last year in collaboration with Mass General Brigham in Boston.

Heuron ICH becomes Heuron’s fifth software package to receive FDA clearance, it said. Others include Veuron-Brain-mN1, Veuron-Brain-pAb, Heuron Beta Amyloid and Veuron-Brain-pAb3.