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.