SAN JOSE, Calif.--(BUSINESS WIRE)--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.
