HEM Hemosense

HemoSense, Inc. (AMEX:HEM) today announced it has received acknowledgement from the U.S. Food and Drug Administration (FDA) that the Company has satisfactorily addressed the concerns about its quality management system detailed in a Warning Letter from the FDA in November 2006. The Company also announced it has successfully completed its first ISO 13485:2003 inspection audit. ISO 13485:2003 is the internationally recognized standard for medical device development and manufacturing, which the Company first achieved in 2006. �Our commitment to maintaining world-class design, manufacturing and quality management systems to provide superior products to our customers is illustrated by these recent developments,� said Jim Merselis, president and CEO of HemoSense. About HemoSense HemoSense is a point-of-care diagnostic healthcare company that develops, manufactures and markets easy-to-use, handheld blood coagulation systems for monitoring patients taking warfarin. The HemoSense INRatio� system, used by healthcare professionals and patients themselves, consists of a small monitor and disposable test strips. It provides accurate and convenient measurement of blood clotting time, or PT/INR values. Routine measurements of PT/INR are necessary for the safe and effective management of the patient�s warfarin dosing. INRatio is sold in the United States and internationally. For more information, visit www.hemosense.com. HemoSense� and INRatio� are registered trademarks of HemoSense, Inc.