FDA approves Eko cardiology technology advances

Earlier this month, Eko, an artificial intelligence (AI) digital health company, was granted FDA approval for its latest cardio-technology.

The US-based company has developed new algorithms for its novel AI stethoscope to allow clinicians to gain AI support in diagnosing various cardiac abnormalities, such as heart murmurs. The stethoscope is also capable of identifying various lung and bowel sounds, so the company has the capability to develop algorithms to aid diagnoses in these other disease areas as well.

This FDA approval is a significant win for Eko, as the start-up is still relatively new to the healthcare market, having been founded in 2013 by students from the University of California, Berkeley, US. In 2019 alone, the FDA approved over 40 different device technologies, many of which were for cardiac-related issues. As the prevalence of cardiac disease rises, devices and technology, such as the AI stethoscope, are becoming increasingly imperative to improve patient outcomes.

Eko’s algorithms are aimed at clinicians with the goal of aiding diagnoses, but the software is patient-friendly and can be used at home or in a clinic setting to produce data sets demonstrating cardiac function. Eko aims to develop further algorithms and disease detection technology, which is likely to occur due to the success of its cardiac algorithms and the $20m funding received by the company in late 2019. This funding has been invested directly in the company’s R&D.

Its success also extends to its latest collaboration with the Mayo Clinic, which has led to its novel heart failure (HF) detecting algorithm receiving breakthrough device designation by the FDA. The digital DUO stethoscope detects left ventricular ejection fraction (LVEF) using a combined mobile device electrocardiogram (ECG) technology. LVEF is a classification used to diagnose the varying subsets of HF: preserved, mid-range and reduced ejection fraction.

Treatment for the different types of HF is becoming increasingly specific, highlighting the importance of correct diagnosis in HF subsets, especially in the case of mid-range ejection fraction, which is a relatively novel classification.

Eko has also joined forces with North Western Medicine to improve valvular heart screening with a low-cost AI alternative and therefore has more potential projects in the pipeline. As AI becomes one of the greatest progressive technologies in modern healthcare, companies, such as Eko, can be expected to reap the rewards of this shifting landscape.

From both aspects, Eko’s AI has a powerful ability to aid clinicians and patients in taking ownership of their health. Although competitors in the landscape have stepped up their AI abilities in the consumer area, such as the ECG functionality of the Apple Watch, Eko is a strong contender in the provider market and its innovation has increased rapidly since launching in 2013, with an updated version of the 2015 approved digital stethoscope reaching the market in 2019.

Diagnostic criteria and techniques are almost as important as the treatment strategy itself, if not more so, as the correct diagnosis leads the clinician to the correct treatment course for the patient. This is especially true in an area such as cardiovascular (CV) health, as many symptoms have crossover between disease states. Furthermore, the screening of potential CV issues can be entirely subjective depending on the skill of the clinician. This means that many potential issues may be missed, leading to further economic spend at a later date when CV events occur.

AI in healthcare has had an impressive start, and it is set to continue as such projects receive further understanding and funding. Companies like Eko will benefit from this focus but due to the fact that the number of competitors in this space continues to increase and improvements are consistently being made to existing products, they will need to continue to invest in innovation to stay ahead of the trends.

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