Aevice Health, a digital health company developing connected respiratory technologies, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its AI-powered Aevice Wheeze Detection Module (K260140), marking a major milestone in the company’s expansion into respiratory decision-support software.
Cleared as a Class II medical device for adults and pediatric patients aged two years and older, the standalone software uses AI to analyze lung sound recordings from compatible FDA-cleared electronic stethoscopes, automatically flagging recordings containing sounds suggestive of wheeze for clinical review.
Bringing AI to Respiratory Assessment
Wheeze is a high-pitched whistling sound produced as air moves through narrowed airways. It can occur in conditions such as asthma, chronic obstructive pulmonary disease (COPD) and some respiratory infections.
Wheeze does not follow an appointment schedule and may occur overnight or between clinic visits.
By adding AI-powered wheeze analysis to recorded lung sounds, Aevice Health gives care teams an additional tool to assess recordings captured outside scheduled appointments.
“This clearance is a major step forward for Aevice Health,” said Adrian Ang, CEO of Aevice Health.
“It expands our capabilities from capturing lung sounds to supporting their assessment with AI. As standalone software, the technology creates opportunities to bring AI-powered wheeze analysis to compatible connected platforms and reach more patients, advancing our mission to make respiratory care more accessible.”
Building Opportunities for Connected Care
The Aevice Wheeze Detection Module analyzes lung sound recordings from compatible FDA-cleared electronic stethoscopes, including AeviceMD, which is already deployed in the United States and Singapore.
Designed as standalone software, the module can also be integrated with compatible FDA-cleared third-party host platforms, opening opportunities for new partnerships and bringing AI-powered wheeze analysis to more care teams and patients.
Regulatory Information
The Aevice Wheeze Detection Module (K260140) is prescription-only decision-support software for evaluating lung sound recordings in adults and children aged two years and older.
Results require advice from a licensed healthcare professional and should be considered alongside the original recording and other relevant patient information.
The module is not intended to detect lung sounds other than wheeze, or for emergency use or self-diagnosis.
AeviceMD holds separate FDA clearances for adults and children aged three years and older (K223382 and K243603).
