FDA Clears Adjunctive AI for Non-Contrast CT of Brain Injuries and Hemorrhages

RapidAI has received FDA 510(k) clearance for Rapid Hyperdensity, an artificial intelligence (AI)-enabled tool that may allow for more timely assessment of traumatic brain injuries and hemorrhages.

Rapid Hyperdensity’s AI-powered review of non-contrast computed tomography (CT) enables radiologists to quickly determine the extent of hyperdense tissue volume associated with acute neurological conditions such as intracerebral hemorrhage (ICH), according to RapidAI.

Alejandro M. Spiotta, M.D., said the automated detection of intracranial hyperdense tissue volume with Rapid Hyperdensity is a significant advance in facilitating timely triage and ongoing assessment of patients with ICH.

“Detection of ICH via AI can save lives by helping to speed up diagnosis and accelerate transfer to the best physician and hospital that can take care of the patient,” noted Dr. Spiotta, the director of the Neuroendovascular Surgery Division at the Medical University of South Carolina. “With the addition of automatic hyperdense volume measurement, physicians can more easily track volume over time and help quickly identify which patients may require an intervention.”