As a part of this AI in Healthcare and Life Science series, I had the pleasure of sitting down with Dr. David Almeida Cardoso PhD, co-founder of Nuroflux, to discuss his company’s product and how AI is revolutionizing the medical devices space. The company is on a mission to transform stroke care with a revolutionary wearable device that monitors brain blood flow in real-time. Imagine having a tech sidekick for your brain that could alert clinicians to trouble before it happens—yes, it is that cool. I met Dr. Cardoso for the first time at an event hosted by Aethos, which is a non-profit start-up hub dedicated to building global communities for ethical AI, and he was gracious enough to agree to be interviewed.

A stroke is a sudden and catastrophic event where the brain’s lifeline—its blood supply—is abruptly cut off, leading to the death of neurons. This rapid neuronal loss can result in profound and often irreversible impairments, affecting speech, movement, cognition, and even personality. But like all such disorders, it doesn’t only affect the patient themselves but also their families and communities. Survivors often face a grueling journey of rehabilitation, and many are left with debilitating disabilities that impede their daily lives. Innovations like Nuroflux’s wearable device offer hope by potentially improving stroke detection for better patient outcomes.

Dr. Cardoso, a scientist turned entrepreneur, shared how his team is tackling one of the most critical gaps in stroke management- delayed recognition, limited access to advanced treatment centers, inconsistent imaging use, and fragmented post-stroke care, all of which hinder optimal outcomes. Below, Dr. Cardoso shares the Nuroflux story, their vision, and what is next for this groundbreaking technology.

Can you, in your words, tell us about the idea behind Nuroflux?

Dr. Cardoso: “Our device offers continuous, 24/7 monitoring of brain blood flow, something current stroke care lacks. The technology leverages conductivity changes in electrocardiogram (EKG) signal propagation to infer dynamic blood flow states. For instance, in ischemic strokes, where vessel blood vessel blood flow is blocked, a signal decrease is observed, while in hemorrhagic strokes, where there is a vessel rupture and localized pooling of blood, a signal increase is observed.”

“Timing is everything in stroke care. Every second saved could mean the difference between full recovery and long-term disability. Our device aims to replace subjective, labor-intensive nursing assessments with objective, real-time “data”

The portability and affordability of the Nuroflux device also make it ideal for underserved communities where access to CT or MRI imaging is limited.

Can you tell us about your background and how Nuroflux came to be?

Dr. Cardoso: “I have always been fascinated by healthcare innovation, largely because of my personal experiences. My mother has epilepsy, and it took two decades of trial-and-error to find a treatment regimen that worked for her. Watching that long, painful process motivated me to explore ways to bridge gaps in healthcare.

“After earning my PhD in biochemistry, I was looking to combine science with real-world impact. A serendipitous introduction by Ben Lindsay, who formerly ran an accelerator program at the University of Sydney, connected me with my now co-founder Dr. Samuel van Bohemen, a PhD in biomedical engineering.

“What drew me in was the simplicity and elegance of the solution,” he explained. “The idea of using EKG conductivity as a proxy for brain blood flow just made sense. It was one of those moments where I thought, ‘Why hasn’t anyone done this before?’”

How does AI factor into this technology?

Dr. Cardoso: “Our approach is data-first, and AI plays a critical supplementary role. Right now, we are focused on collecting and validating data, but as our dataset grows, AI will help identify subtle patterns—particularly in the moments leading up to a stroke.”

“Stroke is not an instantaneous event; there is usually a buildup over seconds or minutes. AI offers the opportunity to extract features from the data that might not be obvious to humans, potentially giving us predictive power. However, we are cautious—clean, well-curated datasets are essential to meaningful AI models. In healthcare, bad data can lead to disastrous outcomes. Garbage in, garbage out so to speak.”

Does Nuroflux have applications beyond stroke care?

Dr. Cardoso: “Yes! Stroke is just the beginning. Conditions like traumatic brain injuries, epilepsy, and even migraines all involve changes in brain blood flow. For instance, we are theorizing how this technology could help identify early warning signs of concussions. The potential is massive.”

Nuroflux’s affordability and portability make it particularly exciting for use in underserved or remote regions. “In areas without access to CT or MRI machines, our device could bridge the gap, offering lifesaving monitoring in real time,” Dr. Cardoso explains.

Nuroflux is currently in the clinical validation stage. The team is working with academic partners to collect data from stroke patients and validate their device’s accuracy and reliability. “Once we gather enough evidence, our goal is to secure venture capital funding for a pivotal trial. This trial will create the final data package required for FDA submission,” explained Dr. Cardoso

While the device is still in its developmental stages, Dr. Cardoso and his team are optimistic about its potential to gain FDA approval in time. “The key is demonstrating clinical sensitivity and specificity. We are confident that, with the data we are collecting, we will be able to make a compelling case.”

As a regulatory affairs graduate student, I am particularly interested in understanding the challenges startups face when navigating regulatory pathways and achieving compliance. Could you share some of the key hurdles Nuroflux has encountered in its journey toward FDA approval?

Dr. Cardoso: “While the potential of Nuroflux’s technology is immense, the journey has not been without its hurdles.”

Funding and Resources:
As a healthcare startup originating in Australia, securing venture capital has been a challenge. “Australia’s startup ecosystem is small compared to the U.S.,” says Dr. Cardoso “There are more healthcare-focused VCs in one building in Boston than in all of Australia. We had to be strategic and patient to get the resources we needed to move forward.”

Regulatory and Compliance Hurdles:
Nuroflux also faces the rigorous demands of regulatory compliance. “Our current device is being validated in an academic setting, but it doesn’t yet meet ISO standards for regulatory-grade hardware and software,” Dr. Cardoso explains. Achieving compliance is a critical step before pivotal trials and FDA submission.

Scaling Clinical Trials:
Gathering enough clinical data to support FDA approval requires significant funding and resources. “Pivotal trials are incredibly expensive, and recruiting enough patients to demonstrate the device’s clinical sensitivity and specificity is a lengthy process. But we are committed to building the strongest case possible for regulatory approval,” Dr. Cardoso says.

Despite these challenges, the team remains optimistic. “Innovation is always a high-risk, high-reward journey,” he adds. “We’re motivated by the potential impact our device could have on millions of lives.”

Dr. Cardoso’s journey—from a childhood marked by his mother’s struggle with epilepsy to leading a company alongside his co-founder at the forefront of wearable health tech—is a testament to the power of combining science with vision. Whether it is saving lives in stroke care or opening new doors in neurology, Nuroflux is proving that innovation does not just improve healthcare—it redefines it.

Key Takeaways:

Continuous Monitoring Redefines Stroke Care

• Nuroflux provides real-time brain blood flow data, replacing subjective nursing assessments with actionable insights.

AI as a Supplement, Not a Shortcut

• By integrating AI, Nuroflux aims to predict strokes before they occur, enhancing early intervention and patient outcomes.

Expanding to Primary Care and At-Home Monitoring

• Integration with healthcare information systems would enable primary care providers to monitor patients post-discharge, offering a continuum of care. Integration and interoperability are key principles being pushed by many research organisations and institutes like Mass-Brigham General, and NIH

Global Impact Through Accessibility

• The device’s affordability and portability make it ideal for underserved communities, especially in remote regions lacking advanced imaging capabilities.

On the Path to FDA Approval

Nuroflux is collecting clinical data to support capital raising that will enable a pivotal clinical trial, a critical step toward regulatory approval and commercialization.

For those who want to learn more about Nuroflux or connect with Dr. Cardoso to discuss the healthcare commercialization more broadly, feel free to reach out via LinkedIn.

Dr. Cardoso