April 19, 2017
Heart Test Labs, Inc., announced today the appointment of Mr. Joe Schwoebel as Vice President of Clinical and Regulatory Affairs.
Heart Test Labs notes Joe Schwoebel has over 30 years’ experience in medical device clinical studies, regulatory affairs, and quality assurance with several companies, including firms that range from large multinationals to startups.
“We are very fortunate to have someone with Joe’s experience, capability and track record of success in this key role at Heart Test Labs,” said Mark Hilz, President and CEO. “Joe is a key addition to our team and will play a pivotal role in advancing our innovative product, MyoVista®, through clinical and regulatory processes.”
Joe Schwoebel has substantial experience with cardiovascular products, comprising an ideal fit with the product focus of Heart Test Laboratories. He has previously worked at Pacesetter Systems, Inc., (acquired by St. Jude Medical), Biotronik GmbH, CardiacAssist, Health Hero Network (acquired by Bosch Healthcare), Pharmaceutical Product Development (PPD), and Neuros Medical, Inc.
During his career, Mr. Schwoebel has secured FDA clearance of 75 510(k)s, 6 Original PMAs, 100+ PMA Supplements, as well as CE Marks (European Union), Canadian MDLs (Canada), and product approvals throughout Asia, Australia, Middle East, Eastern Europe and Russia. He has also organized and completed 12 IDEs leading to market release of medical devices in the United States, European Union, and other major markets.
Joe Schwoebel is an active member of RAPS, SEMDA, and has participated on various committees of AdvaMed located in Washington, DC.