Business Wire04.24.17
Heart Test Laboratories Inc. has appointed Joe Schwoebel as vice president of clinical and regulatory affairs. Schwoebel has more than 30 years of 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, Heart Test 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.”
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 Inc.), Biotronik SE & Co. GmbH, CardiacAssist, Health Hero Network (acquired by Bosch Healthcare), Pharmaceutical Product Development (PPD), and Neuros Medical Inc.
During his career, Schwoebel has secured U.S. Food and Drug Administration clearance of 75 510(k)s, six original pre-market approvals, more than 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 investigational device exemptions leading to the market release of medical devices in the United States, European Union, and other major markets.
Schwoebel is an active member of the Regulatory Affairs Professionals Society, Souteastern Medical Device Association, and has participated on various committees of AdvaMed (the Advanced Medical Technology Associatiion).
Using patented proprietary technology, HTL develops medical devices that focus on the early detection of heart disease. MyoVista’s 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. The company is based in Westlake, Texas.
“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, Heart Test 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.”
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 Inc.), Biotronik SE & Co. GmbH, CardiacAssist, Health Hero Network (acquired by Bosch Healthcare), Pharmaceutical Product Development (PPD), and Neuros Medical Inc.
During his career, Schwoebel has secured U.S. Food and Drug Administration clearance of 75 510(k)s, six original pre-market approvals, more than 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 investigational device exemptions leading to the market release of medical devices in the United States, European Union, and other major markets.
Schwoebel is an active member of the Regulatory Affairs Professionals Society, Souteastern Medical Device Association, and has participated on various committees of AdvaMed (the Advanced Medical Technology Associatiion).
Using patented proprietary technology, HTL develops medical devices that focus on the early detection of heart disease. MyoVista’s 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. The company is based in Westlake, Texas.
