AI stethoscope will save the lives of heart disease patients and has been approved by the US Food and Drug Administration

The U.S. Food and Drug Administration (FDA, referred to as the Food and Drug Administration) has approved the first AI algorithm deployed in a digital stethoscope to allow physicians to accurately detect heart valve disease.

Valvular heart disease occurs when the heart valves do not function properly. Because the valve cannot open or close normally, it will affect the pumping of blood to all parts of the body, and it will also make it difficult for the heart chamber itself to absorb the returning blood.

According to data released by the Centers for Disease Control and Prevention, about 2.5% of people in the United States suffer from valvular heart disease, and tens of thousands of people die from complications such as heart failure or cardiac arrest every year.

Detecting valvular heart disease is often tricky, requiring doctors to listen to a patient's heartbeat and identify abnormal sounds or patterns to determine which valve is damaged and what problem is causing it. However, judgment of heartbeat sounds and patterns is quite subjective, and misdiagnosis or even complete missed diagnosis often occurs.

AI algorithms are expected to help in this regard. Eko, a digital health startup based in Oakland, California, has developed software that analyzes a patient's pulse and helps healthcare professionals detect heart murmurs. This Eko Murmur Analysis Software (EMAS) also became the first software of its kind to receive FDA approval.

Physicians can use the Eko smart stethoscope equipped with EMAS analysis function to collect heartbeat data. EMAS is said to be able to characterize heart murmurs to detect and analyze in seconds which type of valvular heart disease a patient may have.

Eko spokesperson said in an interview, “EMAS is a cloud-based service that allows users to upload heart sounds through an application programming interface and combine them with optional electrocardiogram data for analysis. The software uses signal processing (such as Waveform filtering) and machine learning algorithms analyze the collected data to generate clinical decisions and continuous output for clinicians."

"The EMAS algorithm can analyze heart sound data and output a JSON file with algorithm results. The file is then further passed to the application, which displays it to the user in a human-readable format."

Eko claims that the overall sensitivity and specificity of its EMAS tool, a measure of disease identification accuracy The two indicators) were 85.6% and 84.4% respectively. In comparison, when general practitioners use traditional stethoscopes to detect valvular heart disease, the sensitivity and specificity are reported to be 44% and 69% respectively.

According to a spokesman for Eko, “Clinical experts need years of experience to master the art of auditory interpretation of heart murmurs, and there are still many uncertain variables. Cardiologists have better overall murmur detection accuracy than primary care physicians, but currently most patients are seen only by junior physicians. Only patients with suspected or known heart disease are referred to a cardiologist. "

FDA approval means that Eko can sell its EMAS algorithm in the United States and promote this technology to the entire healthcare industry. "FDA approval is an important step towards commercialization. We are actively seeking cooperation with various medical institutions in the United States. These institutions will become early adopters of EMAS's new solutions and improve their detection capabilities for heart valve diseases. ”

The above is the detailed content of AI stethoscope will save the lives of heart disease patients and has been approved by the US Food and Drug Administration. For more information, please follow other related articles on the PHP Chinese website!