Medical Imaging Startup Aidoc Gets FDA Clearance For AI Solution To Spot Stroke

Aidoc, the Israeli startup that developed AI-powered software that analyzes medical images, announced Monday that the US Food and Drug Administration (FDA) has cleared the company’s AI solution for flagging large-vessel occlusion (LVO) in head CTA scans.

Large-vessel occlusion are defined as blockages of the proximal intracranial anterior and posterior circulation and account for approximately 24 to 46 percent of acute ischemic strokes, according to the National Center For Biotechnology Information (NCBI.)

The company says that together with its previously-cleared AI module for flagging and prioritizing intracranial hemorrhage, this new AI solution can provide “a comprehensive AI package for the identification and triage of both ischemic and hemorrhagic stroke in CTs,” which will accelerate the time it takes to treat the condition.

This marks Aidoc’s fourth FDA-cleared AI package.

“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.

The company has previously received FDA clearance for an AI technology solution that does triage of cervical spine fractures in radiology scans, a solution that flags cases of Pulmonary Embolism (PE) in chest scans, and also has FDA approval to scan images for brain hemorrhages.

The startup also has CE (Conformité Européenne) marking for the identification and triage of (PE) in CT pulmonary angiograms.

“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,” said Yaniv.

Founded in 2016 by Braginsky, Guy Reiner, and Elad Walach, Aidoc was named one of TIME magazine’s 50 Genius Companies of 2018.

The team aims to improve and speed up the radiology workflow, which can be long and tedious. According to the Applied Radiology journal, “radiologists are needing to review one image every three to four seconds to meet workload demands” because of the increase in CTs and MRIs taking place.

Aidoc’s 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.

“Stroke is the ultimate time-critical condition,” said Dr. Marcel Maya,  co-chair of the Department of Imaging at 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.” 

Aidoc has secured $27 million in a Series B round in April 2019, and has raised some $40 million to date.

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