An AI Tool to Identify Cardiovascular Disease Risk Before Symptoms Appear has been Approved by the FDA

 

The FDA approved a novel AI tool that can identify underlying structural heart disease before symptoms appear.

 ·        The first artificial intelligence tool to identify hidden structural heart disease during standard ECGs was approved by the FDA.

·        EchoNext is a cardiac screening designed to detect underlying disease before symptoms arise.

 ·        In a 45-year-old man who eventually underwent a successful heart transplant, the new technique is credited with identifying serious, undetected heart failure.

There is currently no early-detection test for cardiovascular disease, which is the world's biggest cause of mortality. A new tool for early detection of heart disease was approved by the Food and Drug Administration (FDA) on June 22.

According to its manufacturer, Pathway Labs, EchoNext is an artificial intelligence tool that analyses a standard electrocardiogram (ECG) and identifies people at high risk for structural heart disease.

According to the company, the FDA has approved the first AI tool that can identify this type of hidden cardiac illness from an ECG, and the clearance covers six indications.

The first peer-reviewed case in which EchoNext identified significant, undetected heart failure in a 45-year-old patient who eventually had a heart transplant was reported in June in Nature Medicine.

According to the company, Pathway Labs has raised $8.5 million to enter additional health systems and is currently conducting larger trials.

Under the direction of Pierre Elias, MD, founder and CEO of Pathway Labs, an assistant professor of medicine in the Department of Biomedical Informatics at Columbia University Data Science Institute, researchers from New York-Presbyterian and Columbia University developed EchoNext.

In a video released by New York-Presbyterian, Elias stated, "We don't have a screening test for the most common cause of death in the world, which is most forms of cardiovascular disease."

We therefore questioned whether we might use AI to transform a widely available, inexpensive test into a screening test. Elias continued, "And it turns out, we can do exactly that."

How is Structural Heart Disease Detected by the Tool

AI tool recognizes structural heart disease. An issue with the heart's walls, chambers, or valves is known as structural heart disease, and it prevents the heart from functioning normally.

Structural issues are mechanical and don't usually cause blockages, in contrast to a heart attack, which occurs when a blocked artery stops blood flow.

A pump might be forced, stiff, stiff, forcing the heart. Blood may flow backward rather than forward due to a valve leak. Alternatively, the heart muscle may become too weak or bulky to pump effectively.

Because of its quick, noninvasive, and widely available in medical offices and other clinical settings, the electrocardiogram (ECG or EKG) is one of the most popular tests for cardiovascular diseases.

“The heart is a house, and the [ECG] tells us about the electricity. We may occasionally need more testing if the electricity indicates that there might be problems,” according to Rachel Bond, MD, co-chair of the Association of Black Cardiologists' Women and Children Committee.

ECGs have long been used to identify heart attacks and abnormal rhythms, not structural issues that need to be diagnosed with an echo.

EchoNext is designed to close that gap. The tool examines the ECG waveform to identify those who should have an echocardiogram, according to Pathway Labs. Over 700,000 paired ECG and echocardiogram recordings from the New York-Presbyterian health system were used to train the model, according to the company.

EchoNext correctly diagnosed 77% of structural cardiac issues from ECGs alone, compared to 64% of the time when cardiologists analyzed similar ECGs, according to a 2025 study published in Nature.

Six conditions can be flagged by EchoNext. Five of these have been shared by Pathway Labs:

·        Heart failure on the right side

·        Heart failure on the left side

·        Valve disease

·        Extreme heart muscle thickening

·        Pulmonary Hypertension 

These conditions are often. There are a lot of different ways to learn about heart failure and valve disease, according to the Nature study.  

AI Screening Could Lead to Better Early Detection

According to Elias, EchoNext can detect illnesses that "the human eye can't." Additionally, it might assist in eliminating unnecessary testing, which Bond claimed providers tend to underestimate.

According to Bond, "the cost of these tests becomes very much of a strain on our patient populations just in terms of copayment and things of that nature."

According to her, a low-risk ECG reading can save a patient the hours of work, childcare, and transportation required for an additional appointment when it confirms that an echocardiogram is not required.

According to Aaron Horne, MD, a cardiologist and co-chair of the Association of Black Cardiologists' Structural Heart Disease Task Force Program, diagnosis frequently depends on whether a patient is referred for an echocardiogram in the first place and who receives those referrals.

According to a 2020 article published in the Journal of the American Heart Association (JAHA), fewer African American patients receive valve-replacement procedures, including the less invasive transcatheter approach, and the treatment gap continues even though outcomes following treatment are frequently similar by race in some studies.

To swiftly introduce EchoNext to physicians, Pathway Labs is collaborating with OpenEvidence, a platform utilized by medical professionals.

“FDA-approved AI shouldn’t sit siloed in the ivory tower while patients wait years for it to reach them,” Travis Zack, OpenEvidence’s chief medical officer, said in a news release. "A breakthrough in heart disease detection is available everywhere care occurs, from major hospitals to community practices, thanks to EchoNext's placement on OpenEvidence."

Physicians Cautious about Emerging AI Technology

According to Bond, AI should be a contributing factor but not the ultimate decision when making a diagnosis.

"AI is a tool, and we should use it as a single tool for that purpose. "It can't be the final solution," she remarked. "When considering patient care... We also have constraints that are taking a detailed history, a lot of factors that are taking a lot of time.

Bond also cautioned about bias in medicine and prejudice in the training data.

"AI is only as good as the data it is trained on, and the algorithm will perform differently across populations if the training population does not fairly represent people of color, particularly Black patients, women, younger adults, or truly underserved communities." We are therefore carefully examining each of these tools," she stated.

Regarding that point, the Nature study found no clinically significant variations in the model's performance by sex, race, or ethnicity. According to the study, the tool scored approximately 85 out of 100 on a conventional measure of diagnostic accuracy across racial and ethnic groups in the primary test set; this score was similar for Black, White, Hispanic, and Asian patients.

The authors of the Nature article were approached by Healthline, but they were unavailable for comment.

Horne noted that people without access to high-quality care continue to experience healthcare inequities.

"My biggest concern is that when we bring these new technologies, you're further exacerbating the disparity that already exists if we know that some people are starting at a deficit," he stated.

Early detection is crucial, Horne continued. According to studies, the survival probability for severe symptomatic aortic valve constriction is about 50% at 2 years following the onset of symptoms.

Additionally, prevention is essential. According to American Heart Association (AHA) guidelines, Cardiovascular illness prevention largely depends on managing modifiable risk factors. Black women face a greater cardiovascular load and diagnostic disparities, and women's heart disease is still underdiagnosed.

Adopting heart-healthy lifestyle practices, like adhering to the American Heart Association's Life's Essential 8, can help prevent cardiovascular disease, according to experts.