Sunshine Heart Inc (NASDAQ:SSH) announced today the appointment of Megan Brandtto the position of Vice President of Regulatory Affairs and Quality Assurance. In this capacity, Ms. Brandt will facilitate and manage quality and regulatory affairs for Sunshine Heart.
“Megan brings to the company a specific set of necessary skills to successfully guide us through the regulatory approval process as we push forward in our new clinical strategy,” said John Erb, Chairman and Chief Executive Officer of Sunshine Heart. “Her extensive leadership and experience will be critical for the new strategic direction of the company.”
Prior to joining Sunshine Heart, Ms. Brandt was Vice President of Quality and Regulatory Affairs at Cardiovascular Systems, Inc. (CSI), a company focused on developing and commercializing innovative solutions for treating peripheral and coronary vascular disease. At CSI, she successfully facilitated domestic and international clinical study submissions and secured multiple regulatory approvals including CE mark, 510(k) clearances, and original PMA approval for their peripheral and coronary orbital atherectomy systems.
She currently serves as Co-Chair for Medical Alley’s Regulatory Advisory Board and is actively involved in FDA working groups including Harmonization by Doing and MDEpiNet’s RAPID programs. In 2014, she was nominated by Minnesota Business Magazine as an Emerging Healthcare Leader. Ms. Brandt earned her B.S. in Biochemistry and Microbiology from Minnesota State University-Mankato. (Original Source)
Shares of Sunshine Heart Inc closed yesterday at $0.7999, up $0.01 or 1.25%. SSH has a 1-year high of $3.57 and a 1-year low of $0.40. The stock’s 50-day moving average is $0.77 and its 200-day moving average is $0.76.
Sunshine Heart, Inc. engages in the provision of cardiac and coronary disease products. Its activities include development, manufacture and commercialization of medical devices for the treatment of heart failures and diseases. It markets its products under the C-Pulse System brand.