Qure.ai Bags Industry’s First 4-in-1 FDA Clearance for Medical Imaging AI

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#Organizer : FDA / qure.ai #IsTraining : Period #Period : first US FDA 510(k) clearance for its head CT scan product 'qER'.

NEW YORK, June 30, 2020 /PRNewswire/ — Imaging Artificial Intelligence (AI) provider Qure.ai announced its first US FDA 510(k) clearance for its head CT scan product ‘http://www.qure.ai/headct.html” rel=”nofollow noopener” target=”_blank”>qER’.
The US Food and Drug Administration’s decision covers four critical abnormalities identified by Qure.ai’s emergency room product.
Now, the AI tool 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.
There is, therefore, a clear need for a comprehensive and high-quality imaging AI tool to assist healthcare providers with prioritization and image interpretation.
“Our target turnaround time for emergent studies is 30 minutes but leveraging AI for acutely critical conditions enables us to shorten that time.
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,” says Benjamin W.
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,” said Pooja Rao, Co-founder and R&D head, Qure.ai.
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’s other products include a CE-marked chest X-ray AI tool qXR, and COVID-19 progression monitoring solutions for chest X-rays, with both in clinical use in over 20 countries.
For more information, please visit http://www.qure.ai.
About Qure.ai
Headquartered in Mumbai, India, with U.S. operations based in New York, Qure.

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