AI Solution for Flagging Large Vessel Occlusion Receives FDA Approval


Approval of Aidoc's AI package could improve diagnosis and subsequent outcomes for stroke in emergency departments.

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The US Food and Drug Administration (FDA) has approved an artificial intelligence (AI) package from Aidoc for flagging large-vessel occlusion (LVO) in head computed tomography angiography (CTA) scans.

The approval marks the fourth 501(k) clearance for an Aidoc AI solution and—when combined with Aidoc’s previously approved module for flagging intracranial hemorrhage—could provide clinicians increased identification and triage abilities for ischemic and hemorrhagic strokes on CTA scans.

With the newest clearance, Aidoc is now "leading the way in radiology AI," Gal Yaniv, MD, endovascular neurosurgeon and neuroradiologist at Sheba Medical Center and chief medical officer of Aidoc, said.

"I'm proud that Aidoc's FDA-cleared AI solutions for flagging pulmonary embolism, cervical spine fractures and intracranial hemorrhage are in full clinical use, saving lives in more than 300 medical centers across the world," Yaniv said in a statement.

The newly cleared AI package from Aidoc is an always-on solution that continuously scans CTA images for ischemic and hemorrhagic stroke. Use of the solution allows radiologists the ability to diagnose LVO more quickly—improving treatment and outcomes, according to the release.

The clearance of Aidoc’s AI solution is supported by multiple studies, including research from the University of Rochester Medical Center, which demonstrated Aidoc’s ability to reduce turnaround time for emergency room patients with intracranial hemorrhage by 36.6%. Aidoc’s release noted additional research from Yale-New Haven Hospital further confirmed the package’s ability to expedite time to treatment for similar cases.

“Aidoc's comprehensive stroke package flags both large vessel occlusion and hemorrhages inside our existing workflows, ensuring we can diagnose stroke faster and decide on the best course of treatment,” said Marcel Maya, MD, co-chair of the Department of Imaging, Cedars-Sinai Medical Center. “We're already seeing how this has a positive impact on department efficiency and patient length of stay."

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