CE certification for Qure.ai’s traumatic brain injury and stroke triage tool

  • 21 March 2019

Our brain CT scan product, qER has now received CE certification. The new algorithm, which covers both stroke and traumatic brain injury, provides support to physicians reading head CTs in the emergency care setting and helps radiologists prioritize the most critical patients.

Rapid diagnosis and treatment of acute neurological illnesses such as stroke and hemorrhage are critical to achieving positive outcomes and preserving neurologic function. Non-contrast head CT scans are among the most commonly used emergency room diagnostic tools for patients with head injury or in those with symptoms suggesting a stroke or rise in intracranial pressure. Their wide availability and relatively low acquisition time makes them a commonly used first-line diagnostic modality.

qER is the only CE-marked AI algorithm for CT scans that detects the complete range of critical brain lesions including bleeds, infarcts, cranial fractures, mass effect and midline shift. The tool picks up images automatically from the CT device and runs in the background, detecting abnormalities and highlighting critical scans to the physician. qER is compatible with scanners from all major manufacturers, and fits directly into the existing radiology workflow.

The newly certified tool contains an improved (higher sensitivity and specificity) and extended (now includes infarcts and cranial fractures) version of the algorithm described in The Lancet in 2018. More information about product capabilities is available at www.qure.ai/headct.html.

This is Qure.ai’s second CE-certified product, after our chest X-ray algorithm qXR, which received the CE mark in May 2018. Both approvals will go a long way towards furthering our mission to develop clinically validated, accurate AI tools that make diagnostics more accessible and affordable.