FDA grants Qure.ai clearance for its AI-based emergency head CT triage tool

Artificial intelligence firm Qure.ai announced Tuesday that it has received Food and Drug Administration clearance for its emergency head CT triage tool.

As a result of the FDA designation, the company’s AI product—qER—can be used to prioritize radiology scans with intracranial bleeds, mass effect, midline shift, and cranial fractures, according to a June 30 announcement. This is the first U.S. FDA 510(k) clearance for the Mumbai, India-based provider.

The AI company says its tool fits directly into the radiology workflow and flags important cases on the worklist. It’s been subject to “extensive” validation, including a 2018 study published in the Lancet, said Co-founder of the firm Pooja Rao.

“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. The sooner they have in-depth information that helps them make that decision, the better for the patient,” added Rao, who is also head of research and development at the company. “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.”

More than 75 million CT scans are performed in the U.S. each year, and upward of 10,000 people die within a week of discharge from the emergency room. In these situations, minutes can be “life-changing” for patients, vRad Chief Medical Officer Benjamin W. Strong, MD, said Tuesday.

The leading teleradiology provider has completed thorough validation of the product and claims it can lower turnaround times for emergency studies to under 30 minutes.  

“We have done extensive validation of the Qure.ai qER solution and are excited to continue to partner with Qure.ai and improve care for our patients,” Strong added.