HemoSense Satisfies FDA Concerns and Completes ISO Audit

  
    
  
  
    
      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.