Published 30 Jun 2020

Qure.AI gets FDA clearance for head CT AI software


Back has achieved a significant milestone by receiving its inaugural US FDA 510(k) clearance for its pioneering head CT scan tool, 'qER.' This sanction enables the AI-powered solution to effectively triage radiology scans and diagnose intracranial bleeds, mass effect, midline shift, and cranial fractures. The product can uniquely detect cranial fractures and midline shifts, offering a near-comprehensive triaging solution for critical markers on regular head CT scans.
Given the high frequency of CT scans performed in the US each year, this powerful, high-grade imaging AI tool is crucial in aiding healthcare professionals to prioritize and interpret images swiftly and accurately. "The qER plays an instrumental role in providing in-depth information to doctors for making timely, crucial decisions, especially in the context of brain injuries," said Pooja Rao, Co-founder, and R&D Head at
The qER suite is designed to seamlessly blend with the existing radiology workflow, prioritizing critical cases and facilitating quicker and more efficient reporting of time-sensitive health markers. Having undergone rigorous validation and testing, it is now operational at several hospitals and teleradiology providers worldwide.
In addition,'s product range also comprises the CE-marked chest X-ray AI tool qXR and COVID-19 progression monitoring solutions for chest X-rays, which are currently in clinical use across more than 20 countries.

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