Brainomix's AI Brain Imaging Software Receives Green Light from FDA

07 Apr 2023

On March 21st, 2023, Brainomix, a U.K.-based leading provider of artificial intelligence (AI) solutions, received a green light for its new medical imagining innovation from the United States Food and Drug Administration (FDA).

The company announced that its Brainomix 360 e-ASPECTS tool had received clearance from the FDA for supply to U.S. stroke centers.

Moreover, the company’s Brainomix 360 stroke software platform provides a collection of tools enabled by advanced AI algorithms to interpret brain scans in real time, providing doctors with valuable information to guide treatment decisions.

The software has been deployed in over 30 countries and has been studied and validated in more than 60 publications, demonstrating its efficacy and reliability. 

The Brainomix 360 e-ASPECTS is the primary tool of the platform, and it is an automated scoring system that uses non-contrast computerized tomography (CT) scans to generate an ASPECTS (Alberta Stroke Program Early CT Score) score, which is a measure of the severity of a stroke.

Developed by Alastair Buchan, a co-founder of Brainomix and a professor of Stroke Medicine at the University of Oxford, the e-ASPECTS tool has become a key selection criterion for endovascular treatment in all major stroke guidelines.

Endovascular treatment is a minimally invasive procedure used to remove a blood clot in the brain that is causing a stroke. The ASPECTS score helps doctors to determine which patients are the best candidates for this treatment. The score is based on a CT scan of the brain and ranges from 0 to 10. The higher the score, the less severe the stroke.

Moreover, a clinical trial published on PubMed in 2022 evaluates the impact of using machine learning and AI-based analysis software on the delivery of reperfusion therapies for stroke patients at a high-volume primary stroke center. 

The software, e-Stroke Suite, developed by Brainomix, was implemented to analyze non-contrast CT and CT angiography results. 

The trial collected data on consecutive stroke patients admitted to the center from two identical 7-month periods from 2017 and 2018, and the AI imaging software was implemented in the latter period.

The study found that the use of the e-Stroke Suite increased thrombolysis rates from 11.5% to 18.1% and showed a similar trend for thrombectomy.

Moreover, physician feedback suggested that the artificial intelligence-based software increased confidence in decision-making and improved patient outcomes. 

Since the e-ASPECTS tool is powered by explainable AI, it can provide doctors with a clear and transparent explanation of how it arrived at its scoring decision. 
Furthermore, the explainable AI integrated into the e-ASPECTS tool is essential for gaining trust in the system and ensuring that doctors can make informed decisions based on the software's output.

While keeping the clinical trial in mind, Professor Raul G. Nogueira, Director of the University of Pittsburgh Medical Center (UPMC) Stroke Institute, said, "Brainomix has generated an impressive breadth of evidence and validation data for its e-ASPECTS tool."

In January 2023, the company has recently formed a strategic partnership with Blackford, a leading provider of imaging AI platform and solutions. As part of this collaboration, Blackford will distribute the software through its wide-reaching network. 

Dr. Michalis Papadakis, CEO and Co-Founder of Brainomix, said, “Our technology supports these physicians who are making time-sensitive, critical decisions around transfer and treatment, strengthening networks, and facilitating an improved stroke service."

Dr. Papadakis added, "We are delighted to have the opportunity to now take our technology to the US, where more than 800,000 patients suffer a stroke each year.”

Moreover, the increasing development of artificial intelligence (AI)-enabled products, such as e-ASPECTS, and the increasing regulatory approvals for them, will lead to the growth of the AI-enabled medical imaging solutions market.

According to data insights from BIS Research, the global AI-enabled medical imaging solutions market was valued at $1.85 billion in 2022 and is anticipated to reach $18.35 billion by 2032, witnessing a CAGR of 25.76% during the forecast period 2022-2032.


The advancements in MedTech, such as the integration of deep learning, machine learning, and AI-based technologies in medical imaging solutions, will transform the healthcare industry. 

With the ability to reduce treatment costs and provide easy medical access and regular patient check-up reports, AI-based medical imaging solutions are reducing patient visiting times, resulting in faster treatment and improved patient health.

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