Artificial intelligence specialist wins FDA clearance for brain injury CT software

The U.S. Food and Drug Administration has granted clearance to an artificial intelligence-driven CT tool used to diagnose and track brain injuries.—headquartered in New York and Mumbai—announced the news Thursday, gaining 510(k) clearance for its brain CT quantification software qER-Quant.

Clinicians using this platform can assess the severity of numerous brain conditions, including hemorrhagic stroke, hydrocephalus and traumatic brain injuries. The software can also track the progression of such injuries. now has two clearances under its belt, earning the first in June 2020.

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

Rao said the updated tool is based on feedback from radiologists, neurologists and emergency department physicians who wanted automatic volume measurement capabilities for their neurology scans to assess patients’ progress and aid in discharge decision making.

It’s also cleared for marketing in the EU and is being used across more than 40 healthcare sites, according to the company.

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