Qure.ai lands second FDA clearance for AI-based brain scan technology

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qure.aiQure.ai has announced US Food and Drug Administration (FDA) 510(k) clearance for its brain computed tomography (CT) quantification product qER-Quant. Clinicians in the USA can now use this artificial intelligence (AI)-based tool to rapidly and precisely assess the severity of injury in patients with conditions like traumatic brain injury, haemorrhagic stroke, and hydrocephalus, and to track the progression of pathology over time, according to a company press release.

The release adds that AI assistance speeds up treatment and transfer decisions, helps monitor patients more closely, and reduces the chances of diagnostic errors, when deployed in CT scans of patients with brain injuries.

Ajith Thomas, associate professor of Neurosurgery at Harvard Medical School and co-director of the Brain Aneurysm Institute at Beth Israel Deaconess Medical Center (Boston, USA), said: “The use of AI will be transformative in the management of traumatic brain injury by obtaining an expedient and accurate diagnosis. Congratulations to Qure.ai for being at the forefront of this paradigm shift!”

“Qure.ai’s technology makes it possible to systematically measure brain haemorrhages precisely and rapidly in patients with stroke, or trauma. Fully automated quantification could soon become the standard of care,” said Johan Wasselius, interventional neuroradiologist at the Skåne University Hospital and Lund University (Lund, Sweden).

“This FDA clearance adds quantification, outlining and measurement capabilities to Qure.ai’s first clearance for triage and notification of critical brain abnormalities,” said Pooja Rao, co-founder and R&D head at Qure.ai. “We are excited about bringing a complete suite of capabilities to clinicians who deal with critical head CT scans.”

“We have always built products to solve real customer challenges and qER-Quant is another example of the same,” said Prashant Warier, CEO and co-founder of Qure.ai. “We worked on this capability based on customer feedback from radiologists, neurologists and ER [emergency room] physicians who expressed the need to get automated volume measurements on neuro scans to assess patient progress—as well as safe discharge decisions. It helps us offer a more comprehensive suite of AI tools to our US clinical partners.”

The company’s AI tool is also cleared for marketing in the European Union, and is currently used by teleradiology providers, emergency care physicians and radiologists at more than 40 clinical sites, helping to process thousands of scans every day, the Qure.ai release concludes.


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