Aidoc Gets FDA 510(k) Clearance for AI-Powered Algorithm for Brain Aneurysms

Could a new artificial intelligence (AI)-enabled advance have an impact in the diagnosis and treatment of brain aneurysms?

The Food and Drug Administration (FDA) has granted 510(k) clearance to Aidoc’s new AI platform for brain aneurysms. In addition to identifying and triaging suspected cases, the algorithm facilitates communication and workflow between radiologists, neurologists and neuroendovascular surgeons, according to the company.

Researchers have estimated that approximately 6.5 million people in the United States have an unruptured brain aneurysm.¹ The Brain Aneurysm Foundation has noted that most aneurysms are small, ranging from 1/8 inch to an inch, and ruptured aneurysms are reportedly misdiagnosed or there is a delay in diagnosis in 25 percent of patients who present to health-care providers.¹

Elad Walach, the CEO and co-founder of Aidoc, said the new AI-enabled algorithm may help enhance timely diagnosis and care for brain aneurysms.

“In the U.S., 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,” maintained Walach. “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.”

Reference

1. Brain Aneurysm Foundation. Available at: https://www.bafound.org/about-brain-aneurysms/brain-aneurysm-basics/brain-aneurysm-statistics-and-facts/#:~:text=An%20estimated%206.5%20million%20people,aneurysm%20ruptures%20every%2018%20minutes. Accessed April 8, 2022.