US FDA PR re Laser Device for Diabetics

[Mike Grissom <mikeg@SLAC.Stanford.EDU>]

radsafe'rs,

The following US Food and Drug Administration press
release should be of special interest to laser
persons:

----------
HHS NEWS

   U.S. Department of Health and Human Services

FOR IMMEDIATE RELEASE
FOOD AND DRUG ADMINISTRATION
P98-38

                  December 7, 1998

Print Media:         301-827-6242
Broadcast Media:     301-827-3434
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.

                     ####

ATTENTION TV BROADCASTERS: Please use open caption
for the hearing impaired.


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The above may be viewed on the Web at URL:

 http://www.fda.gov/bbs/topics/NEWS/NEW00667.html


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