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HEar disease remains the number one killer of Americans, killing nearly 700,000 people each year. It’s estimated that more than 6 million Americans have heart disease, but they may not know it. But about half of them have a risk factor that means their heart isn’t pumping blood as effectively as it could, something doctors call a “low ejection fraction.” Catching it early can help prevent more serious heart disease, but it often goes undetected because there are few symptoms.

Eko Health, a startup that develops a digital stethoscope and its software, aims to change that. On Tuesday, the Food and Drug Administration approved an algorithm co-developed by Mayo Clinic and Eko that allows Eko’s AI stethoscope to accurately detect low ejection fraction. (Clinical studies found that it was able to accurately identify it about 85% of the time.) This allows primary care physicians using Eko’s stethoscope to detect heart failure symptoms during routine exams, possibly before symptoms of heart failure appear. , potentially allowing identification of at-risk patients. .

“Doctors will receive early warning of heart disease,” said Eko CEO Connor Landgraf. forbes. “And we can actually help patients get to interventions sooner, like cardiologists, pulmonologists, surgeries.”

Founded in 2013, Eko Health has sold more than 500,000 digital stethoscopes. According to Pitchbook, the company has raised $125 million in venture backing so far, and its valuation is estimated at $415 million. Mayo Clinic is an investor in the company through its venture arm, as are ARTIS Ventures, 3M’s venture arm, and Highland Capital Partners.

This is not Eko’s first FDA approval. In 2020, the agency also gave the green light to an algorithm that can accurately detect atrial fibrillation and heart murmurs, which can be early warning signs of more serious conditions such as heart failure and stroke.

The algorithm was first developed at the Mayo Clinic, said Paul Friedman, director of the clinic’s cardiovascular division. The clinic has developed a machine learning algorithm for electrocardiogram machines that can detect reduced ejection fraction when a person is connected to the machine. This algorithm was licensed to his Eko, who adapted it for use in their own stethoscopes.

“These tools are incredibly powerful. They can help screen for conditions for which there are treatments,” said Friedman, who tested the tools in a retrospective study and found they outperformed traditional methods such as treadmill testing. It added that it was also found to be able to more accurately detect heart problems. Measure oxygen and other vitals.

In a peer-reviewed study published in lancet In January 2022, researchers at Imperial College London, which is not affiliated with Eko, found that the algorithm detected reduced ejection volume in patients about 85% of the time. It was approved in the UK in November 2023 and doctors are using the algorithm across multiple primary care sites within the country’s National Health Service.

Now that the FDA has cleared the algorithm, the company plans to begin piloting it with select customers, followed by full commercialization of the software system in the United States. In the meantime, Landgraf said the company will continue to develop new algorithms. We have developed a digital stethoscope algorithm to provide an even wider range of diagnoses.

“We frequently release new algorithms that unlock new capabilities,” he said. “And it makes this tool even more useful for the clinicians who use it. We have put the device in the field, but now we need to unlock new value with a new generation of AI tools. ”

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