Aevice Health Secures US FDA Clearance for Smart Wearable Stethoscope-Enabled Remote Respiratory Monitoring

21 July 2023 | Friday | News

Aevice Health, a leading provider of remote respiratory monitoring solutions for the healthcare continuum and backed by the Cedars-Sinai Accelerator, announced that its flagship medical device, 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.
The AeviceMD

The AeviceMD

The AeviceMD received U.S. FDA 510(k) clearance as a Class II medical device. The AeviceMD is part of a broader system that continuously monitors biomarkers of  interest to detect early signs of respiratory exacerbation. 

  • As a portfolio company of the Cedars-Sinai Accelerator, the company is working  towards a pilot with the health system. 

Coronet Ventures, the international Cedars-Sinai organization, along with East  Ventures, a leading sector-agnostic venture capital firm in Southeast Asia, will be participating in Aevice Health's bridging round.


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. 

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.

Asthma and COPD, the two most common chronic respiratory diseases, account for  over 41 million patients in the US, with authorities expecting the actual prevalence to be higher  due to underdiagnosis. These diseases contribute significantly to hospital emergency  department visits and readmissions, accounting for over $130B1,2in direct and indirect costs  for the country. Lack of access to post-discharge care and follow-ups are key drivers of the  hospitalizations and readmissions.  

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. 

“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 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,” said Adrian Ang, CEO of Aevice Health. 

As a participant in the Cedars-Sinai Accelerator Class 8, Aevice Health has received  invaluable support from the program during its developmental journey in the US. Over the  course of the three-month program, the company underwent rigorous mentorship, refining its  product-market fit for the US market and strategically shaping its product launch strategy. This  was made possible with guidance from clinical key opinion leaders, executive management,  operations members of the health system, and investors. As part of their plans, the company  is working towards a pilot program with the Cedars-Sinai Medical Center.  

Additionally, Coronet Ventures, the international Cedars-Sinai organization, and East  Ventures, a leading sector-agnostic venture capital firm in Southeast Asia, will be joining  Aevice Health’s bridging round with an undisclosed investment. 

2023 has been a momentous year for the AeviceMD thus far. This announcement  comes at the heels of the company’s recent Singapore Health Sciences Authority (HSA) first in-market approval for the AeviceMD Monitoring System in March. Earlier in January, the  device was awarded the coveted CES® 2023 Best of Innovation Award in the digital health  category, an award recognizing the best of breakthrough technologies improving health equity  and saving lives. 

This FDA-clearance is the first for the product and paves the way for expanded  indications that encompass the full range of features offered by the platform. This includes the  AeviceMD Monitoring System’s proprietary lung-sound analyzing algorithm which the  company plans to clear in near future


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