VeriChip gets approval

Applied Digital Solutions, Delray Beach,
Fla., the manufacturer of VeriChip, has been pursuing this regulatory
approval single-mindedly for the past two years, and on Oct. 13 the FDA
finally authorized the chip’s use in medical applications.

Approval was a long time in coming: Two and a
half years ago, Applied Digital claimed that the FDA had approved the
chip, but in reality FDA had only asked the company for more
information, which its developers interpreted as approval. Later, the
FDA did give its approval, but not for medical applications.

The most recent clearance came on the heels
of the FDA’s new regulatory philosophy to encourage novel technology.
In a speech delivered at the 2004 Medical Innovation Summit a week
after the VeriChip approval, Lester Crawford, FDA acting commissioner,
said: “In recent years, our emphasis on innovation has become much more
intensive and comprehensive. And we’re not afraid of out-of-box ideas
that serve our objectives.

“Our agency is deeply involved in the use of
new information technology to help prevent medication errors, collect
adverse events data and improve our operational efficiency. The best
known of these innovations is our requirement, which was announced in
February, that all prescription drugs and OTC [over-the-counter]
products used in nursing homes and hospitals should be bar-coded with
the National Drug Code Number to avoid mistakes in their dispensing and
administration. The same principle is used in the implantable chips and
scanners of the VeriChip system our agency approved last week,” he said.

Over 30 million of the chips, developed over
the past 15 years, have been sold so far to the companion pets and dog
and cat industry. The company also sells approximately 27 million
electronic visible tags for the livestock industry annually. With this
kind of history and around a thousand people implanted internationally
to date (primarily for security applications), the company expects the
clearance to open up the way for the chips’ use in a variety of medical
applications.

“With FDA clearance, we are now free to
market VeriChip in the United States for what I believeis the best
application of this product, the medical application,” said CEO Scott
Silverman. “Through a managed database, VeriChip can act as a portal to
medical records, medical device information, personal information and
insurance information within milliseconds at the point of treatment,
such as a doctor’s office, an emergency room, a hospital or an
ambulance.”

The VeriChip Health Information System will
consist of a subdermal radio frequency microchip, an inserter, a
proprietary hand-held scanner and a secure database containing the
patient-approved healthcare information. Once inserted under the skin
in a brief outpatient procedure, the rice-grain-sized device cannot be
seen by the human eye. Each chip contains a unique, 16-digit
verification number that is captured by briefly passing a proprietary
scanner over the implanted area; the number then links to a central
database via encrypted Internet access. The previously stored
information can then be conveyed via the Internet to the registered
requesting healthcare provider. HST

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