FDA approves Aevice Health's pediatric wearable stethoscope technology for use
In the rapidly evolving digital health landscape, two companies are making strides in respiratory care. Aevice Health, the innovator behind the AeviceMD, a smart wearable stethoscope, and electronRx, a developer of a smartphone app for lung function monitoring, are both making waves.
AeviceMD, designed with a pediatric-friendly approach, has received FDA 510(k) clearance for use in pediatric patients aged 3 years and above. Adrian Ang, CEO of Aevice Health, expressed that this clearance extends their reach to vulnerable pediatric patients, marking a significant step forward in their mission to reshape home-based respiratory monitoring. The AeviceMD uses clinically validated AI and has a pediatric-friendly design to provide objective data for monitoring patients with chronic respiratory diseases from home. It functions as a hospital-at-home tool, supporting earlier interventions, reducing readmissions, and extending care beyond traditional clinical settings.
On the other hand, electronRx is planning to launch a smartphone app for remote lung function monitoring. However, it's not specifically designed for pediatric patients, nor does it have FDA 510(k) clearance. The app is not a hospital-at-home tool, nor does it support earlier interventions, reduce readmissions, or extend care beyond traditional clinical settings. Moreover, it does not use clinically validated AI or have a pediatric-friendly design.
As of July 2025, Aevice Health is actively expanding its reach, with plans to accelerate commercialization efforts, focusing on expanding enterprise partnerships and home care programs. Following the successful Seed Plus round in late 2024, led by Coronet Ventures, the U.S. venture arm of Cedars-Sinai Intellectual Property, Aevice Health has seen participation from institutional and corporate investors such as SEEDS Capital, East Ventures, Denka Company, A&D Company, and Elev8 VC.
Meanwhile, electronRx has not disclosed any commercialization plans or focus on expanding enterprise partnerships and home care programs. The company's app is not currently deployed across leading hospitals in the U.S. and Singapore.
While both Aevice Health and electronRx are making strides in respiratory care, the former is currently leading in terms of FDA clearance, pediatric focus, and comprehensive functionality. The benefits of soft skin adhesives using silicone elastomer technology, as discussed in "Medical Plastics Insights", are likely to be harnessed by Aevice Health in the development of the AeviceMD. On the other hand, AccurKardia, another player in the digital health field, has received FDA breakthrough device designation for an AI-powered hyperkalemia detection solution.
[1] Source: Aevice Health Press Release, July 2025 [2] Source: FDA Listing of FDA-Cleared Sensor-Based Digital Health Devices, Accessed July 2025 [3] Source: Digital Health Today, List of FDA-Cleared Wearable Health Devices, Accessed July 2025 [4] Source: Venture Capital Post, Agtech Investment Summaries, Accessed July 2025
- In the realm of digital health, Aevice Health, equipped with FDA 510(k) clearance, is extending its reach to pediatric patients, leveraging clinically validated AI and a pediatric-friendly design to revolutionize home-based respiratory monitoring.
- ElectronRx, on the other hand, is primarily focused on launching a smartphone app for remote lung function monitoring in adults, but it does not have FDA 510(k) clearance, nor is it designed for pediatric patients or equipped with clinically validated AI.
- As of July 2025, Aevice Health, backed by corporate investors like Denka Company and Elev8 VC, is actively expanding its reach, focusing on commercialization, enterprise partnerships, and home care programs, while electronRx has yet to disclose similar intentions.
