Heart Test Labs Achieves Significant Milestone With ISO 13485 Certification

WESTLAKE, Texas--(BUSINESS WIRE)--Heart Test Laboratories, Inc. has achieved ISO 13485:2003/NS-EN ISO 13485:2012 certification for its quality management systems. The certification includes activities related to the design and development, manufacturing, distribution and servicing of active non-invasive electrocardiographic devices for screening for a variety of cardiac abnormalities and disease.

“This is a significant step in the process of commercializing the MyoVista technology and demonstrates HTL’s commitment to deliver a high quality product. Our team spent months working diligently to obtain EN ISO 13485 certification”

ISO 13485 is an International Organization for Standardization (ISO) standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 is now considered to be the standard and a requirement for medical devices including "Global Harmonization Task Force Guidelines" (GHTF). Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The FDA's Quality System Regulation 21CFR Part 820 contains requirements for medical device manufacturers and is harmonized with ISO 13485 in terms of the quality management systems requirements thus allowing a significant amount of the work to benefit towards meeting FDA QMS system requirements.

“This is a significant step in the process of commercializing the MyoVista technology and demonstrates HTL’s commitment to deliver a high quality product. Our team spent months working diligently to obtain EN ISO 13485 certification,” said Mark Hilz, President and CEO.

About Heart Test Laboratories, Inc. (“HTL”)

HTL develops medical devices using patented technology that focus on the early detection of heart disease. The MyoVista’s innovative technology facilitates the early identification of ischemic and other heart abnormalities which can enable improved screening for coronary arterial disease and other cardiac abnormalities.

The MyoVista provides two tests in one and is easy to use by all physicians. By using standard 12-lead resting ECG protocols, the MyoVista provides an ECG test incorporating interpretive analysis, as well as its easy to understand proprietary informatics that assist a physician in screening for heart disease at an early stage. The MyoVista is designed to assist a physician by providing additional information in the decision process of referral of patients to a cardiologist for further diagnostic testing and treatment.

The MyoVista has a 15.6 inch high resolution touchscreen and incorporates user features and functionality commonly associated with a tablet device which make it intuitive and easy to use thereby reducing training time. Its proprietary informatics provide information to physicians that are suggestive of ischemic and certain types of other structural heart abnormalities. The MyoVista is ideally suited for use in both primary care and hospital environments.

Heart Disease kills 7 million people worldwide each year, more than all cancers combined, and is the largest spend area in healthcare. The MyoVista® helps to address the “diagnostic gap” in heart disease today, which is the identification of asymptomatic patients prior to an adverse cardiac event, such as a heart attack.

HTL expects to seek FDA clearance and CE Mark for the MyoVista in the near future. Heart Test Laboratories is a privately held U.S. corporation which to date has been funded by private investors. For more information, visit hearttestlabs.com.