Cardiomedics, Inc., a pioneer in the world of external counter pulsation (ECP), is leading the way in the diagnosis, treatment and management of cardiovascular disease.Cardiomedics Inc. is committed to continuing its pioneering role in developing new tools for cardiovascular medicine and enhancing patient's healthcare and quality of life. Cardiomedics, Inc. ALWAYS LEADING THE WAY.The CardiAssist currently has two FDA 510(k)s. Number K872034 clears the CardiAssist for the treatment of angina, acute myocardial infraction and cardiogenic shock. Number K022107 clears the CardiAssist for the treatment of congestive heart failure. Cardiomedics, Inc. is ISO 9001, ISO 13485, and CE certified.