Soundable Health

Soundable Health, established in 2017 by founder and CEO Catherine Song, PhD, operates as a digital health company focused on developing digital audible biomarkers through AI-powered sound analysis. The company targets underserved chronic conditions where accessible monitoring tools are lacking, aiming to improve early detection and symptom management. Its business model revolves around creating software as a medical device (SaMD) solutions that transform smartphones into health monitoring tools for use by patients, healthcare providers, and clinical researchers.

The company has secured capital across several funding rounds from investors including Samsung Ventures, NAVER, IMM Investment, and Dunamu. Headquartered in San Jose, CA, with a presence in South Korea, Soundable Health has established various clinical and strategic partnerships, including being selected for the Google for Startups Cloud Program.

Soundable Health's product pipeline features two main applications. The first, proudP®, is an FDA-listed Class II medical device designed for urology. It allows patients, particularly those with conditions like benign prostatic hyperplasia (BPH), to perform uroflowmetry at home by simply recording the sound of their urination with a smartphone. The app's AI algorithm analyzes the sound to measure parameters such as peak flow rate and voided volume with an accuracy clinical studies have found to be comparable to in-office uroflowmetry. The data is accessible to medical professionals through a dedicated dashboard for remote monitoring. The second product, Coughy®, is a remote monitoring tool that quantifies cough frequency and characteristics. It analyzes cough sounds recorded via smartphones or wearables, providing objective data for pharmaceutical clinical trials and respiratory patient management. The AI for Coughy was developed using over 100,000 clinical cough samples, and its privacy-preserving technology removes background conversation during analysis.

Keywords: digital biomarkers, acoustic AI, health monitoring, remote patient monitoring, digital health, urology, respiratory health, software as a medical device, clinical trials, sound analytics