Aevice Health gains FDA clearance for respiratory monitoring platform
Remote respiratory monitoring solutions company Aevice Health has announced that it has received clearance from the US Food and Drug Administration (FDA) for its flagship medical device, the AeviceMD, as a Class II medical device under the 510(k) route.
This clearance allows the company to market and provide the novel remote monitoring platform to health systems across the US, expanding access to a more convenient solution for assessing lung health in both clinical and home settings.
The AeviceMD forms part of the company’s wider AeviceMD Monitoring System, which is a comprehensive patient management platform aimed at managing chronic respiratory disease. The system continuously monitors biomarkers of interest via its smart wearable stethoscope as well as detecting the early signs of respiratory exacerbation.
The system has been assessed in trials analysing abnormal lung sounds compared to the current standard of care, clinicians’ own stethoscope-based analysis. Results from these trials are currently being compiled and are likely to be disclosed in a later press release.
Adrian Ang, CEO of Aevice Health, commented: “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. Unfortunately, the patients requiring these solutions the most often are often the ones facing challenges in accessing adequate care. With this clearance, we take a significant stride towards becoming the equivalent of continuous glucose monitors for diabetes, but for respiratory health – a patient-centric, affordable and accessible solution that empowers patients to achieve a healthy recovery from the comfort of their homes.”
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