HHS NEWS

U.S. Department of Health and Human Services


FOR IMMEDIATE RELEASE                FOOD AND DRUG ADMINISTRATION
P98-38                               Print Media:         301-827-6242
December 7, 1998                     
                                     Consumer Inquiries:  888-INFO-FDA

FDA CLEARS FIRST AT-HOME LASER FOR PEOPLE WITH DIABETES

The Food and Drug Administration today granted market clearance to a first-of-a-kind device that offers people with diabetes a means of drawing blood without using traditional lancets (small, razor-sharp devices for puncturing the skin). The device, the Cell Robotics' Lasette, is a portable, battery operated Erbium:YAG laser that can be used in the home after patients have received a prescription and requisite instruction from their health care provider.

"Today's action may improve the quality of life for many Americans who suffer from diabetes," said Dr. Donald B. Burlington, Director of FDA's Center for Devices and Radiological Health. "It highlights the many important ways that advanced technologies can contribute to our everyday health care needs."

According to the American Diabetes Association, an estimated 10.3 million Americans diagnosed with diabetes must draw blood samples for blood/glucose level analysis once or twice a day. Traditionally these patients have had to prick their fingers with lancets to get these samples. This process can be particularly difficult for children.

The Cell Robotics' Lasette uses laser energy to penetrate the skin. Clinical testing has shown that adequately trained patients can perform finger pin pricks with the laser device as easily and accurately as with lancets. The lasette has been proven effective with both adults and juveniles who have diabetes.

As with any laser device, the Cell Robotics' Lasette requires proper maintenance and instruction in order to be used safely and effectively. For example, the laser must be kept clean in order to preserve its accuracy. Patients will receive this training and instruction material from the prescribing health care provider. The Lasette is manufactured and distributed by Cell Robotics, Inc. Of Albuquerque, N.M.

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