Qure.ai Gets 510(k) Clearance for Brain CT Device

Qure.ai has received the FDA’s 510(k) clearance for its artificial intelligence-based brain computed tomography quantification software, qER-Quant.

The software is designed to precisely assess the severity of injury in patients with conditions like traumatic brain injury, hemorrhagic stroke and hydrocephalus, and to track the progression of pathology over time.

This is the New York City-based company’s first U.S. clearance for triage and notification of critical brain abnormalities. The product was previously cleared for marketing in the EU.