Dawn Burleson

FUSMobile, Inc.

Dawn received her Bachelor of Science in Nursing (BSN, RN) degree from Georgia Southern University, her Master’s in Business Administration degree with a focus in Leadership Development from Brenau University, and is currently working on her Masters of Science in Nursing and Adult Geriatric Primary Nurse Practitioner certification with Chamberlain University. She has been active in the medical device industry for 25 years and has had the opportunity to participate in moving many devices from conceptualization to commercialization. She has experience with a variety of regulatory submissions – 510(k), de novo, and premarket approvals (PMA). Dawn has been involved in multiple areas of study with emerging technologies, such as the Beta-Cath System™ for cardiac in-stent restenosis (Novoste/Best Medical), the PillCam™ endoscopy platform (Given Imaging/Medtronic) for small bowel/colon visualization, and the Sonablate™ high-intensity focused ultrasound device for prostate tissue ablation (SonaCare Medical/Sonablate HIFU), and the Hygieacare™ System for colon hydrotherapy and microbiome sampling (Hygieacare/Lifestream). She has managed and monitored several studies as well as supported manufacturers in their medical device reporting (MDR) and clinical evaluation report (CER) submission responsibilities. She has co-authored more than 15 poster presentations and publications. She started consulting in 2018 and assists medical device companies with their clinical/regulatory projects. She currently works with FUSMobile, Inc. overseeing their clinical investigation and regulatory submissions for a high-intensity focused ultrasound device used to ablate neural tissue for pain management. Dawn and her husband live in Florida with their cat and three dogs, they enjoy gardening, biking, boating, and scuba.