Elsa Chi Abruzzo, RAC, FRAPS, is a medical device executive, entrepreneur, and a founding member of Anuncia Medical, Alcyone LifeSciences, Arthromeda, Inc., and Cygnus Regulatory with a 35+ year successful product development, manufacturing, regulatory, quality, and clinical record of accomplishment in medical devices. Cygnus Regulatory, her consulting firm, specializes in regulatory and clinical strategy, execution, and due diligence. Elsa successfully led teams at various start-ups, bringing many disruptive medical solutions to market. She authored or contributed to 4 granted US FDA Breakthrough Devices Designations. Ms. Abruzzo held leadership roles at Cordis JNJ, CryoLife, Percutaneous Valve Technologies (acquired by Edwards Lifesciences), AtriCure (IPO), Sapheon (acquired by Covidien/Medtronic), and PTS Diagnostics (acquired by Sinocare). Ms. Abruzzo has a B.S. in engineering, is regulatory affairs certified, and is a Fellow of the Regulatory Affairs Professional Society.