A Florida company Thursday said that it will begin marketing and selling a microchip that can be implanted under the skin, after receiving the go-ahead from the U.S. Food and Drug Administration (FDA).
The FDA advised the company, Applied Digital Solutions (Nasdaq: ADSX), that its biochip, called “VeriChip,” is not considered a medical device and therefore is not subject to FDA regulation.
FDA officials said that as long as the biochip is used for identification purposes only, it will not have to meet strict FDA guidelines. The ruling saves the product from having to undergo the agency’s rigorous and lengthy safety testing procedures.
“The FDA said that VeriChip has no medical function, and Applied Digital Solutions is now free to sell, market and insert the chips in individuals,” company spokesperson Matthew Cossolotto told NewsFactor.
‘Distinction Without a Difference’
Although the company has advertised the VeriChip in the past as a potential method of storing a person’s complete medical history, at this stage the device will contain only a number to be used for identification.
However, that ID code can be transmitted via Internet or phone to a secure data storage site, where it can be cross-referenced, allowing authorized personnel to obtain detailed medical information.
“In some ways, it’s kind of a distinction without a difference,” Cossolotto said. “We could have, and we might in the future, put more information on the chip. But right now we’re very happy to put just the ID verification code and start getting it into the marketplace.”
The company said it has targeted VeriChip and its “life-enhancing” technology toward patients who may arrive at hospitals unconscious or unable to speak, as well as at workers who need top-security clearance.
The biochip also could prove valuable for tracking children, Alzheimer’s patients and convicted felons on parole.
Similar technology has been used in the last few years to keep track of pets.
Politicians, Felons and Kidnap Victims
A South Florida man, Jeff Jacobs, is expected to be the first recipient of the VeriChip. The plight of the Jacobs family has been well publicized: Jacobs, a 41-year-old dentist, must take up to 10 medications a day for a variety of ailments, including cancer and a degenerative spinal condition.
According to his family, Jacobs has arrived at emergency rooms several times unable to speak.
The company also said the chip could be combined with a global positioning system [Latest News about global positioning system] (GPS) and used for security purposes by potential kidnap victims.
ADS, which has estimated that the worldwide market for security chips will reach US$450 million by 2007, already has deals in place in South America.
Brazilian politician Antonio de Cunha Lima has been trying to become the first South American to use the implant chip, according to published reports. Brazil has the fourth highest kidnap rate in the world, after Colombia, Mexico and Indonesia.
First Florida, Then the World
The company, which first announced the chip in December 2001, said it will launch the product in the next three weeks, first in Florida and then nationwide and internationally.
The biochip is a miniature, implantable radio frequency identification device (RFID) roughly the size of a grain of rice. It is composed of “FDA-accepted materials,” according to the company, and each chip contains a unique verification number.
That number is “captured” by passing a scanner over the chip, causing a small amount of radio frequency energy to pass through the skin and activate the dormant chip. The chip then transmits the verification number on a radio frequency of 125 KHz.
A doctor is required to perform the implant procedure, which can be done for free at certified clinics under local anesthesia, according to ADS officials. The chip itself is expected to sell for around US$200. The scanner will cost up to $3,000, although ADS said it is considering giving them away to hospitals and medical clinics.
‘Mark of the Beast’
The VeriChip is not without controversy. It has been challenged by privacy and political advocates, who say that if the chip were to fall into the wrong hands, totalitarian regimes could use it to track political dissidents.
The technology also could be used as a tool in a national ID system — an idea that has waned in popularity since peaking right after the September 11th terrorist attacks.
A March survey by Gartner Dataquest showed that 41 percent of those surveyed in the United States oppose a national ID system, while just 26 percent support one.
Also, some religious sects have said the biochip is the “Mark of the Beast” from the Book of Revelations. They claim that a graphic the company used early in the product’s life cycle “clearly” resembled the satanic numbers “666.”