ROCKVILLE, Md., Dec. 7 /PRNewswire/ -- 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.
SOURCE Food and Drug Administration
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Related links:
http://www.fda.gov
CONTACT:
FDA, Print Media, 301-827-6242, Broadcast
Media, 301-827-3434, or Consumer Inquiries, 888-INFO-FDA
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