Aevice Health has announced they received FDA 510(k) clearance for its smart wearable stethoscope AeviceMD. Credit: grandbrothers/Shutterstock

Singapore based remote respiratory monitoring provider Aevice Health has announced they received US Food and Drug Administration (FDA) 510(k) clearance for its smart wearable stethoscope AeviceMD.

The AeviceMD medical device is one part of a wider system which monitors biomarkers nonstop bringing to attention signs of respiratory irregularities. It does this using proprietary algorithms on data gathered by the wearable stethoscope which is fed to the AeviceMD Monitoring System platform.

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The device is designed for patients using remote patient monitoring (RPM) and clinicians will be able to digitally perform auscultations from listening and monitoring recordings from the device. These healthcare professionals will be able to spot abnormalities and prompt patients to the right care to protect lung health.

According to the American Thoracic Association, asthma costs the US economy more than $80 billion annually in medical expenses. They also estimate asthma and Chronic Obstructive Pulmonary Disease (COPD) account for over 41 million patients in the US with post-discharge care and follow-ups contributing to readmissions to hospitals.

The device and system have been tested in an emergency hospital setting, with results from these trials planned to be released in a separate announcement.

Aevice Health believe the FDA clearance will allow them to expand into the US market providing a convenient solution to manage lung health. Adrian Ang, CEO of Aevice Health said: “This FDA clearance represents a remarkable milestone for our company. While diseases like diabetes or heart failure have seen advancements in technology, there remains a notable lack of comprehensive solutions for respiratory conditions.” He added: “With this clearance, we take a significant stride towards becoming the equivalent of continuous glucose monitors for diabetes, but for respiratory health.”

In March 2023 Aevice Health received Singapore Health and Science Authority (HSA) approval for the smart wearable stethoscope in Singapore.

According to a GlobalData report the RPM market was valued at $585.5 million in 2022 and is expected to grow to $760 million in 2030. The report also states, as technology advances and hospitals integrate more software, we can expect to see a growth in software as a medical device (SaMDs) in RPM and other healthcare sectors.