Sequoia-backed Qure.ai gets USFDA nod for CT scan, first for Indian AI firm

American regulator's decision covers four critical abnormalities identified by Qure.ai's emergency room product namely intracranial bleeds, mass effect, midline shift, and cranial fractures

Sequoia-backed imaging Artificial Intelligence provider Qure.ai has received the US Food and Drug Administration’s clearance for its head CT scan product qER, becoming the first Indian AI company to receive the regulator's approval. 

The FDA's decision covers four critical abnormalities identified by Qure.ai’s emergency room product namely intracranial bleeds, mass effect, midline shift, and cranial fractures.

“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,” said Pooja Rao, Co-founder and R&D head, Qure.ai.  

According to data, every year, over 75 million CT scans are performed in the US, and more than 10,000 people die within 7 days of an emergency room discharge. The qER suite plugs directly into the radiology workflow and prioritises critical cases on the worklist. This 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. 

Headquartered in Mumbai, Qure.ai product portfolio also includes 'chest X-ray AI tool qXR, and Covid-19 progression monitoring solutions for chest X-rays, in clinical use in over 20 countries.