AI stroke treatment package receives FDA clearance
AI stroke treatment package receives FDA clearance

It’s the fourth clearance the company has had from the FDA. Combined with Aidoc’s previously-cleared AI module for flagging and prioritising intracranial haemorrhage, together they provide an AI package for the identification and triage of both ischemic and haemorrhagic stroke in CTs.

Dr. Marcel Maya, co-chair Department of Imaging, Cedars-Sinai Medical Center, said: “Stroke is the ultimate time-critical condition. 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 haemorrhages 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.” 

During a stroke 1.9 million neurons and 14 billion synapses die each minute, making fast diagnosis and treatment critical. Improved medical imaging and better treatments have made it possible to clear occlusions in the brain’s arteries using thrombolysis or mechanical thrombectomy; however, haemorrhage 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 scans images for both ischemic and haemorrhagic 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 haemorrhage, 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 centre for treatment. Aidoc's combined stroke solution ensures that the diagnosing facility and the stroke centre 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 haemorrhage by 36.6%. Research by Yale-New Haven Hospital confirmed Aidoc’s impact in expediting the time to treatment for these critical cases. 

Gal Yaniv, endovascular neurosurgeon and neuroradiologist at Sheba Medical Center and chief medical officer of Aidoc, said: “With our fourth 501(k) clearance, Aidoc is leading the way in radiology AI with the most comprehensive FDA-cleared AI triage package. I’m proud that Aidoc’s FDA-cleared AI solutions for flagging pulmonary embolismcervical spine fractures and intracranial haemorrhage are in full clinical use, saving lives in more than 300 medical centres across the world.”

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