Mumbai-based healthcare AI startup Qure.ai earlier this week announced its first US FDA 510(k) clearance for its head CT scan product qER. The US Food and Drug Administration’s decision covers four critical abnormalities identified by Qure.ai’s emergency room product.
The AI tool can now be used to triage radiology scans with intracranial bleeds, mass effect, midline shift, and cranial fractures. Qure.ai claims that two of these capabilities – cranial fractures and midline shift are exclusive to qER. This means that the newly cleared qER suite will be able to triage nearly all critical abnormalities visible on routine head CT scans.
WHY IT MATTERS
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. A comprehensive and high-quality imaging AI tool such as qER can assist healthcare providers with prioritization and image interpretation.
HOW IT WORKS
The qER suite plugs directly into the radiology workflow and prioritizes critical cases on the worklist. 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.
THE LARGER TREND
In February 2020, Qure.ai raised $16 million in funding led by Sequoia India and was supported by MassMutual Ventures Southeast Asia, MobiHealthNews reported. The fresh funds will be used for geographical expansion, product portfolio expansion and to support regulatory clearances.
ON THE RECORD
“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. 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 in a statement.
Original Article: (https://www.mobihealthnews.com/news/asia-pacific/qureai-gets-fda-clearance-its-head-ct-scan-product-qer#)