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Healthcare AI Provider Aidoc Gets New FDA 510 (k) Clearance for Brain Aneurysm

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The Israel-based provider of artificial intelligence healthcare solutions, Aidoc has received its 9th FDA 510 (k) clearance for triage and notification of brain aneurysm. This announcement further strengthens Aidoc’s position as the leading provider of the most comprehensive, enterprise-grade clinical AI platform, including the broadest neuroscience suite offered to clinicians around the world.

 

One out of 50 people suffer from a brain aneurysm in the U.S. each year. Overlooked 10 percent of the time, incidental positive cases often go unnoticed due to their small size and complexity of blood vessels in the brain. If ruptured, patients face a 50 percent chance of fatality. Adding to its repertoire of neuro solutions that include LVO (M1), ICH and C-spine fractures, Aidoc’s newly FDA-cleared solution now flags and communicates suspected positive cases of brain aneurysm.

 

The brain aneurysm solution delivers a care coordination workflow that is tailored to radiologists, neuroendovascular surgeons and neurologists, who need to treat multiple and different types of patients, whether from the emergency room, outpatients, at the hub, or transfered from the spoke.

 

“In the U.S., there is tragically a brain aneurysm rupture every 18 minutes. It’s 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’re 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 9th FDA clearance in three years, we stay committed to providing the most comprehensive platform in the space.”

 

Aidoc’s AI platform enables 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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