RAIsonance, Inc., the leader in artificial intelligence-powered analysis of FCV, announced today it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), a U.S. government agency.
The contract consists of just over $749,000 allocated to the continued development of RAIsonance’s AudibleHealth Dx Software as a Medical Device (SaMD). The device is designed to analyze a user’s Forced Cough Vocalization (FCV) in the diagnosis of illness, with the current focus on both COVID-19 and Influenza. The cloud-based artificial intelligence processing platform uses a mobile app interface for cough collection and is designed to deliver test results in about 2 minutes within the app. The primary objectives of the contract are to complete the execution of the clinical validation studies for COVID-19 and Influenza and to complete a de novo submission to the U.S. Food and Drug Administration before the end of 2023.
Kitty Kolding, Co-Founder and CEO at RAIsonance
“We are elated to have BARDA’s support. Their strategic guidance and extensive expertise will speed our efforts to deliver the best possible diagnostic SaMD to market and help ensure that we fulfill our mission to meaningfully impact global health with such an innovative diagnostic solution.”
RAIsonance’s SaMD is designed to use only software to diagnose disease, without any wet or biological samples of any kind. The non-invasive test requires just 10 intentional coughs, submitted via a uniquely devised mobile application. Tests can be delivered on-demand electronically, are independent of supply chains, and are not limited by shelf-life expiration. The SaMD is scalable – able to process 20,000 tests per second – an ideal solution for large organizations, colleges and universities, and government agencies.
This award is one component of BARDA’s rapidly expanding DRIVe Medical countermeasures portfolio; visit https://drive.hhs.gov to learn more.
“This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00015.”