India-based imaging artificial intelligence (AI) provider Qure.ai has received 510(k) clearance from the US Food and Drug Administration (FDA) for its head CT scan solution qER.

Qure.ai’s qER solution can be used for early triage of all critical abnormalities visible on routine head CT scans, including intracranial bleeds, mass effect, midline shift and cranial fractures. It plugs directly into the radiology workflow and prioritises critical cases on the worklist.

The solution considerably reduces the time taken to open critical scans. It helps to improve the patient outcomes for those with time-sensitive abnormalities.

The company noted that the qER solution has undergone extensive validation, including a 2018 peer-reviewed publication in The Lancet. It is also deployed at many hospitals and teleradiology providers worldwide.

Qure.ai co-founder and R&D head Pooja Rao said: “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.

“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.”

More than 75 million CT scans are performed in the US every year with approximately 10,000 people dying within seven days of an emergency room discharge.

The new tool is aimed at offering a comprehensive high-quality imaging AI tool to assist healthcare providers with prioritisation and image interpretation, the company noted.

Qure.ai’s portfolio of medical imaging AI also includes CE-marked chest X-ray AI tool qXR and Covid-19 progression monitoring solutions for chest X-rays.

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