Wavely Diagnostics, Inc.

Wavely Diagnostics, Inc. develops WavelyDx®, an FDA-listed Class II Exempt diagnostic device that enables parents to screen for middle ear fluid and potential ear infections at home using acoustic echography. The system consists of disposable ear tips that attach to an iPhone and a mobile application that transmits soft sound waves to detect fluid behind the eardrum. Clinical validation demonstrates 84.5% accuracy—exceeding traditional otoscope examination. WavelyDx facilitates early identification of ear infection indicators, reduces unnecessary clinic visits, and enables virtual care consultation through partnered telehealth providers. Designed for pediatric home use, the device addresses the clinical reality that only 1 in 3 ear infection clinic visits confirm positive findings, helping families make informed care decisions and avoid unnecessary antibiotic exposure.