Stroke AI Package Receives FDA Clearance

This week, we received FDA clearance for the triage of Large-Vessel Occlusion (LVO) in head CTA scans, completing the commercial availability of our stroke package and further cementing our comprehensive offering of AI solutions (most comprehensive AI triage suite out there). Combined with our previously-cleared module for Intracranial hemorrhage, health institutions are now able to utilize AI for triage of both ischemic and hemorrhagic stroke in CTs, speeding time to treatment when every second counts.

The news of our recent FDA clearance comes off the heels of the annual RSNA, with a central theme entitled “See Possibilities Together”. I couldn’t think of a better phrase that fits our vision of creating robust AI that works with radiologists, taking real pain points into consideration and creating new clinical workflows around real solutions.

At RSNA 2019, we saw hundreds of AI vendors on display, all sharing fascinating ideas that are pushing the market forward at a rapid pace.  Yet, with so many vendors, some focusing on dedicating pathologies, and others, taking a more comprehensive approach, healthcare institutions should be aware of some essential criteria to consider when selecting an AI vendor. And, of course, regulatory clearance being one of the most necessary for swift adoption and deployment. 

Seeing deeper: Aidoc’s Complete Stroke Package

Since deploying Aidoc’s complete stroke package, we’ve worked diligently with our clinical partners to achieve the highest level of patient care, showing outcomes beyond the hype – and into the future of an AI-driven workflow. 

Aidoc’s Always-on solution continuously scans images for both ischemic and hemorrhagic stroke, automatically and instantly flagging suspected cases in the radiologists’ worklists. Aidoc’s integrated solution provides a single context for radiologists to diagnose both LVO and hemorrhage, so they can quickly decide whether to escalate a case to a specialist stroke center for the most appropriate course of treatment. 

Communication is of the utmost importance when it comes to stroke treatment. Aidoc’s solutions allow for timely and convenient review of patients’ NCCT and CTA scans, as well as the ability to expand communication between institutions, thus leveling the standard of assessment and diagnosis within the network. Ultimately, clinicians can rest assured that a unified platform is helping them reduce outliers in treatment while improving communication. 

Additionally, the solutions expedite care by notifying radiologists immediately, thereby shaving time off the diagnosis while maintaining a high level of quality at the same time.  Here’s just one example of what the stroke workflow looks like with Aidoc’s AI showing an impact in areas such as eligibility for tPA and eligibility for thrombectomy.

stroke workflow

By shortening both door to needle and in turn, door to thrombectomy time, AI has the ability to positively impact the functional independence scores of patients who suffer from a stroke. As noted in this recent JAMA study, the magnitude of the association between treatment time and outcomes is clinically meaningful. 

Jama study

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.

How does AI detect stroke in practice?

This specific case illustrates how AI can work in practice to flag and prioritize urgent cases. A 60-year old man arrived at the ED complaining of symptoms of fatigue and weakness, he was sent for a full head CTA of the brain. The clinical indication was ℅ right side weakness, the finding in a later detailed report was M2 occlusion on the left side. By flagging the right type of occlusion within 45 minutes of his arrival in the ED, this significantly helped reduce the communication time to the stroke team.

More generally, when we speak about using AI to detect strokes, Aidoc’s solution can be customized based on the specific facility treatment paths and can be integrated with the radiology PACs or RIS to ensure immediate action. Aidoc’s LVO algorithm allows connection to regional institutions by tailored alerts to the designated stroke teams for suspected relevant findings, enabling urgent cases to be communicated to stroke centers in real time. Aidoc’s solutions work with radiologists to speed up efficiency, time to treatment, and improve quality of care.

Artificial Intelligence Stroke Clearance

The FDA decision is Aidoc’s fourth 501(k) clearance. Our FDA-cleared AI solutions for flagging pulmonary embolism, cervical spine fractures and intracranial hemorrhage are in full clinical and commercial use in more than 300 medical centers across the world. 

About Aidoc:

A leader in AI healthcare, Aidoc is one of Time Magazine’s 50 Genius Companies and its founders were recognized in Forbes’ “30 under 30” list. The company’s solutions analyze medical imaging to provide the most comprehensive solution AI offering in the field. Aidoc is used by radiologists worldwide, aiding them in maximizing their clinical performance and expediting patient care.

In 2019, Aidoc’s pulmonary embolism solution won the “Best New Radiology Software” Minnie award. Aidoc is currently deployed across five continents and has analyzed more than 3.2 million scans in clinical workflows. 

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