Aevice Health Secures FDA Clearance for Smart Stethoscope Wearable for Respiratory Monitoring

What You Should Know: 

– Aevice Health, a Singapore-based provider of remote respiratory monitoring solutions today announced that its AI-powered, smart stethoscope wearable, the AeviceMD, has received clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device under the 510(k) route. 

– This clearance empowers the company to market and provide their novel remote monitoring platform to health systems across the country, expanding access to a hassle-free and convenient solution for assessing lung health in clinical and home settings.

Remote Respitoring Monitoring Platform

The AeviceMD is an integral part of the broader AeviceMD Monitoring System, a comprehensive patient management platform targeted towards chronic respiratory disease management. Leveraging cutting-edge proprietary algorithms, the AeviceMD Monitoring System continuously monitors biomarkers of interest acquired by its smart wearable stethoscope and detects early signs of respiratory exacerbation. The robust platform has completed trials in the emergency department for the analysis of abnormal lung sounds like wheezing against the current standard of care — the clinicians’ own stethoscope-based analysis. The results from these trials are currently being collated and will be disclosed in a separate and forthcoming announcement.

How AeviceMD Works

With the AeviceMD, the clinic can now be brought home. The AeviceMD elevates the ubiquitous stethoscope – an essential tool in every clinic – into a smart, digital, and easily accessible device. Caregivers and patients can simply conduct auscultations using the AeviceMD sensor and conveniently share them with their healthcare professional. Through analysis of these recordings, healthcare providers can accurately identify abnormalities and promptly advise patients, enabling proactive management of lung health.

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