Monday, January 20, 2020
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FDA Clears Aidoc’s Complete AI Stroke Package

Monday, January 20, 2020

Aidoc provides AI solutions for radiologists. Today they announced that the US Food and Drug Administration (FDA) has cleared its AI solution for flagging Large-Vessel Occlusion (LVO) in head CTA scans, marking Aidoc’s fourth FDA-cleared AI package. Combined with Aidoc’s previously-cleared AI module for flagging and prioritizing intracranial hemorrhage, together they provide a comprehensive AI package for the identification and triage of both ischemic and hemorrhagic stroke in CTs, speeding time to treatment when every minute counts.

“Stroke is the ultimate time-critical condition,” said Dr. Marcel Maya, Co-chair 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 large vessel occlusion 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.”

5% of all deaths in the USA are from stroke, and it is one of the major causes of disability. During a stroke 1.9 million neurons and 14 billion synapses die each minute[1], making fast diagnosis and treatment critical. Improved medical imaging and better treatments have revolutionized stroke care, making it possible to clear occlusions in the brain’s arteries using thrombolysis or mechanical thrombectomy; however, hemorrhage must be ruled out before administering a thrombolytic agent. The faster the time from door-to-treatment for patients suffering from stroke, the more likely a patient will survive without serious neurological impairment.

Aidoc’s always-on solution continuously scans images for both ischemic and hemorrhagic stroke, automatically moving suspected cases to the top of radiologists’ worklists. Aidoc’s 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, patients are diagnosed with stroke in a smaller facility before being moved to a specialist stroke center for treatment. Aidoc’s combined stroke solution ensures that the diagnosing facility and the stroke center can work together in a coordinated manner to expedite patient care.

Research performed by the University of Rochester Medical Center showed Aidoc’s ability to reduce turnaround time for emergency room patients with intracranial hemorrhage by 36.6%. Research by Yale-New Haven Hospital confirmed Aidoc’s impact in expediting the time to treatment for these critical cases.

“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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