WESTLAKE, Texas--(BUSINESS WIRE)--Heart Test Laboratories, Inc., announced today the appointment of Mr. Joe Schwoebel as Vice President of Clinical and Regulatory Affairs. Mr. 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 multinational 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.”
Mr. 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.
Mr. Schwoebel is an active member of RAPS, SEMDA, and has participated on various committees of AdvaMed located in Washington, DC.
About Heart Test Laboratories, Inc. (“HTL”)
Using patented proprietary technology, HTL develops medical devices that focus on the early detection of heart disease. MyoVista’s innovative technology facilitates the early identification of ischemic and other heart myocardial dysfunctions, which can enable improved screening for coronary arterial disease and other cardiac abnormalities. MyoVista® uses standard 12-lead resting ECG protocols to provide a traditional ECG incorporating interpretive analysis, as well as further proprietary informatics to assist a physician in identifying the presence of heart disease. MyoVista® is ideally suited for use in both primary care and hospital environments, and has a 15.6-inch high-resolution touchscreen and incorporates many user features and functionality commonly associated with a tablet device, which makes it intuitive and easy to use, thereby reducing training time.
Heart Disease kills 7 million people worldwide each year, more than all cancers combined, and is the largest spend area in healthcare. MyoVista® helps to bridge the “diagnostic gap” in heart disease today, which is the identification of patients prior to an adverse cardiac event, such as a heart attack.
Heart Test Laboratories is a privately held U.S. corporation which to date has been funded by private investors. For more information, visit www.hearttestlabs.com