FDA Clears AI Solution For Flagging Large-Vessel Occlusion

  • Cryptogenic stroke
  • Hemorrhagic stroke
  • Imaging and testing
  • Intracranial hemorrhage
  • Ischemic stroke
  • Large vessel occlusion
  • Neuroimaging

The Food and Drug Administration (FDA) has cleared an artificial intelligence (AI) solution (Aidoc, Tel Aviv, Israel) that identifies large-vessel occlusion (LVO) on head CT angiography. This is the the fourth FDA-cleared AI package. Combined with the previously cleared AI module for flagging and prioritizing potential intracranial hemorrhage, this provides a comprehensive AI package for the identification and triage of both ischemic and hemorrhagic stroke on CT, speeding time to treatment when every minute counts. 

The University of Rochester Medical Center showed the AI solution ability to reduce turnaround time for individuals in the emergency room with intracranial hemorrhage by 36.6%. Yale-New Haven Hospital confirmed the impact in expediting the time to treatment for these critical cases. 

The AI solution continuously scans images for both ischemic and hemorrhagic stroke, automatically moving suspected cases to the top of radiologists' worklists. The integrated solution provides a single context for radiologists to diagnose both LVO and hemorrhage, so they can quickly decide on the most appropriate course of action. Often, individuals are diagnosed with stroke in a smaller facility before being moved to a specialist stroke center for treatment. The combined stroke solution ensures that the diagnosing facility and the stroke center can work together in a coordinated manner to expedite patient care.

"Stroke is the ultimate time-critical condition," said Dr. Marcel Maya, cochair Department of Imaging, Cedars-Sinai Medical Center. "The faster we can identify, diagnose, and treat it, the better the outcome for patients. Aidoc's comprehensive stroke package flags both LVO and hemorrhages inside our existing workflows, ensuring we can diagnose stroke faster and decide on the best course of treatment. We're already seeing how this has a positive impact on department efficiency and patient length of stay."   

"With our fourth 501(k) clearance, Aidoc is leading the way in radiology AI with the most comprehensive FDA-cleared AI triage package,'' said Gal Yaniv, MD, Endovascular Neurosurgeon and Neuroradiologist at Sheba Medical Center and chief medical officer of Aidoc. "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."

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