Aidoc gains FDA 510(k) clearance for AI-supported triage and notification of brain aneurysm

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Aidoc has received US Food and Drug Administration (FDA) 510(k) clearance for the triage and notification of brain aneurysm—which affects one in 50 people in the USA each year and for which rupture is associated with a 50% chance of fatality, according to a press release from the company.

The newly approved brain aneurysm solution flags and communicates suspected positive cases of brain aneurysm. It is intended to deliver a care coordination workflow that is tailored to radiologists, neuroendovascular surgeons and neurologists who need to treat multiple, differing types of patients—whether from the emergency room or an outpatient setting, at the hub, or transferred from the ‘spoke’—the release states.

“In the USA, there is tragically a brain aneurysm rupture every 18 minutes. It is an acute condition that can quickly turn fatal, so time is of the essence, especially for late night reading,” said Elad Walach, co-founder and CEO of Aidoc. “We are excited to include this algorithm in our set of neuro solutions, addressing the challenge of providing timely and accurate notifications of brain aneurysm cases. With this ninth FDA clearance in three years, we stay committed to providing the most comprehensive platform in the space.”

This recent clearance adds to Aidoc’s repertoire of neuro solutions that also includes artificial intelligence (AI)-based solutions for M1 large vessel occlusions (LVOs), intracranial haemorrhage (ICH) and C-spine fractures. Aidoc claims that its platform enables the “seamless addition” of new AI solutions as a native part of the workflow, eliminating the need to train current and new personnel as additional solutions are adopted by the hospital.


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