Qure.ai said it has received FDA clearance for its first head CT scan product.
The San Mateo, CA-based company’s technology is called qER and can be used to triage radiology scans with intracranial bleeds, mass effect, midline shift, and cranial fractures.
Two of these capabilities – cranial fractures and midline shift – are exclusive to Qure.ai's product. This means that the newly cleared qER suite will be able to triage nearly all critical abnormalities visible on routine head CT scans.
"Patient outcomes depend directly on the onset-to-treatment time, especially for brain injuries,” Pooja Rao, Co-founder and R&D head, Qure.ai., said in a release. “Every day doctors are required to weigh the benefits of a potentially life-saving surgery vs. the risks of an intracranial bleed or other complication. The sooner they have in-depth information that helps them make that decision, the better for the patient. This is where qER plays a key role. We wanted to offer a comprehensive solution to the clinicians, rather than a partial one that triages on the basis of limited or even single findings.”
The company said the qER suite plugs directly into the radiology workflow and prioritizes critical cases on the worklist. This triage drastically reduces the time taken to open critical scans, so those with time-sensitive abnormalities get to be read and reported faster, leading to better patient outcomes.
Qure.ai made headlines earlier this year when it struck an accord with Neve-Ilan, Israel-based Nanox. The agreement called for Qure.ai’s diagnostic solution to be integrated into the Nanox.CLOUD platform.