AI Nears FDA Submission After 99.5% Heart Failure Detection at Mayo Clinic

SYDNEY, Australia – November 24, 2025 – Australian medical technology firm Echo IQ has announced the successful completion of a pivotal clinical validation study for its artificial intelligence software, EchoSolv HF, conducted in collaboration with the prestigious Mayo Clinic. The study, which evaluated the software's ability to detect heart failure from echocardiograms, yielded exceptional results that surpassed the company's own expectations and mark the final clinical hurdle before a planned submission to the U.S. Food & Drug Administration (FDA).

This milestone moves Echo IQ from a developmental stage to the brink of entering the lucrative U.S. healthcare market with a tool designed to address one of cardiology's most significant challenges. The company is now finalizing its 510(k) submission, which it expects to lodge with the FDA in the coming weeks, setting the stage for a potential commercial launch in 2026.

A Landmark Validation at a Premier Institution

The validation was conducted through the Mayo Clinic Platform’s ‘Validate’ program, a service designed to provide independent, objective evaluation of third-party AI models. By testing algorithms against the Mayo Clinic's vast and diverse de-identified patient data, the program acts as a rigorous, real-world proving ground for emerging medical technologies, lending significant credibility to the outcomes.

In this study, EchoSolv HF was tasked with analyzing a dataset of approximately 17,000 individual patient echocardiograms. The results were striking. The software achieved a sensitivity of 99.5%, meaning it correctly identified nearly every patient who truly had heart failure, minimizing the risk of dangerous missed diagnoses. Furthermore, it demonstrated a specificity of 91.0%, accurately identifying patients who did not have the condition, which is crucial for reducing unnecessary follow-up tests and patient anxiety.

These performance metrics are critical in a clinical setting. High sensitivity ensures that clinicians can trust the tool to flag at-risk patients, while high specificity provides confidence that the alerts are meaningful. This combination is essential for any decision support tool aiming for widespread adoption.

In a statement, Echo IQ's Chief Executive Officer, Mr. Dustin Haines, emphasized the importance of the independent validation. “Completion of this clinical validation study represents a major milestone in the commercialisation of EchoSolv HF,” he said. “The independent confirmation of our model’s accuracy and reliability through the Mayo Clinic Platform’s Validate program have exceeded internal expectations and provides strong objective evidence supporting the clinical utility of EchoSolv HF in real-world settings, particularly compared to existing diagnostic tools being utilised across the US.”

Targeting a Critical Gap in US Healthcare

The potential impact of EchoSolv HF is underscored by the scale of the heart failure crisis in the United States. The condition affects millions, with estimates suggesting that one in four Americans will develop heart failure in their lifetime. Despite its prevalence, it remains a diagnostic challenge; currently, only about 50% of all cases are accurately diagnosed. This diagnostic gap is particularly wide for certain forms of the disease, such as heart failure with preserved ejection fraction (HFpEF), which can present with subtle signs on a standard echocardiogram.

This failure to diagnose early and accurately carries a staggering human and economic cost. Heart failure is the leading cause of rehospitalization for adults in the U.S. and is responsible for an estimated 17% of the nation's total healthcare expenditure. According to data from the National Institutes of Health (NIH) and other peer-reviewed economic studies, the annual direct costs associated with heart failure range from $40 billion to over $60 billion, a figure projected to grow as the population ages.

Echo IQ's technology is designed to directly address this gap. By using AI to analyze the complex data within an echocardiogram—the standard imaging test for cardiac function—EchoSolv HF can identify hidden patterns that may be invisible to the human eye. This allows it to flag potential cases of heart failure that might otherwise be missed, enabling earlier intervention, better patient management, and potentially reducing the costly cycle of hospitalizations.

The Regulatory Path and Competitive Landscape

With the clinical validation complete, Echo IQ's focus now shifts to the regulatory process. The company will pursue clearance through the FDA's 510(k) pathway, a common route for Software as a Medical Device (SaMD). This process requires the company to demonstrate that EchoSolv HF is “substantially equivalent” to a legally marketed predicate device in terms of intended use, safety, and effectiveness. The robust data from the Mayo Clinic study will form the core of this submission. The company has prior experience with this process, having already secured 510(k) clearance for a separate product, EchoSolv AS, which aids in the detection of aortic stenosis.

However, Echo IQ is not entering an empty field. The AI-powered cardiology diagnostics space is becoming increasingly active, with several well-funded competitors also targeting heart failure. UK-based Ultromics, for instance, has also collaborated with the Mayo Clinic and has an FDA-cleared product, EchoGo, specifically designed to detect HFpEF from echocardiograms. Similarly, Eko Health has gained FDA clearance for its AI-powered digital stethoscopes, which can detect low ejection fraction—a key indicator of heart failure—from heart sounds, positioning it as a rapid screening tool in primary care settings.

While the market is competitive, the sheer scale of the undiagnosed heart failure problem suggests there is room for multiple innovative solutions that offer distinct advantages in workflow, accuracy, or clinical application.

Commercial Strategy and Market Opportunity

Should Echo IQ receive FDA clearance, the company plans an aggressive commercial rollout in the U.S. The Sydney-based firm is a pre-revenue entity, reporting a net loss in its last fiscal year as it invested heavily in research and development. However, it recently secured A$17.3 million in a capital raise, declaring itself “fully funded” to execute its U.S. commercialization strategy.

This strategy involves leveraging an existing footprint of partnerships with U.S. entities like Sclmage and MedAxiom to build a distribution network. The goal is to integrate EchoSolv HF seamlessly into existing cardiology workflows, making it an easy-to-adopt tool for hospitals and clinics looking to enhance their diagnostic capabilities.

The successful validation at a world-class institution like the Mayo Clinic provides a powerful marketing tool and a foundation of clinical credibility. As healthcare systems globally grapple with rising costs and an aging population, technologies that promise to improve accuracy, efficiency, and patient outcomes are poised for significant attention. For Echo IQ, the successful completion of this study is not just a technical achievement but a crucial business catalyst, moving its promising technology one step closer to making a tangible impact on patient care.