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510(k) clearance applies to four critical abnormalities; two are exclusive to Qure.ai’s product.
The U.S. Food & Drug Administration has granted imaging artificial intelligence company Qure.ai its first 510(k) clearance for its emergency room head CT scan product qER.
This move marks the first time the industry has seen a four-in-one clearance. With the FDA’s decision, qER can be used to triage radiology scans with intracranial bleeds, mass effect, midline shift, and cranial fractures, covering nearly all critical abnormalities seen on routine head CT scans. Two capabilities – cranial features and midline shift – are exclusive to the Qure.ai project, company official said.
With more than 75 million CT scans performed in the United States annually and more than 10,000 people dying within seven days of emergency room discharge, there is a need in the industry for an AI imaging tool that can help providers prioritize and interpret images, said company leaders.
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“Patient outcomes depend directly on the onset-to-treatment time, especially for brain injuries. Every day, doctors are required to weigh the benefits of a potentially life-saving surgery versus the risks of an intracranial bleed or other complication,” said Pooja Rao, co-founder and head of Qure.ai’s research and development. “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.”
According to company information, because time is critical in dealing with many emergency room situations, such as intracranial hemorrhage, the goal is to continue to shorten the 30-minute turnaround time goal that exists for acutely critical conditions. To help reach that aim, the qER suite plugs directly into the radiology workflow, accelerating critical case prioritization.