Vice President – Clinical, Regulatory & Quality Affairs
Mary Lou has over 30 years of experience and has successfully guided five startups through US approval. Prior to joining SOMNERA, she served as the Vice President of Regulatory, Clinical & Quality at four startup companies: Reshape Medical, USGI Medical, SenoRx and Focal. Her regulatory and clinical experience also includes senior management positions with cardiovascular and surgical device manufacturers. Mary Lou has designed and successfully executed numerous clinical studies used to support PMA approvals and 510(k) clearances. From 2001 to 2005, she served as the industry representative on the FDA Obstetrics and Gynecology Devices Advisory Panel. Mary Lou led Somnera through the rigorous FDA de novo request process in 2017, which was granted in just five months. Recently, Mary Lou secured 510(k) clearance of the Somnera System in just 112 days. Ms. Mooney holds an MS in Biomedical Science from Drexel University and a BA in Biology from La Salle University.
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