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510k Application Submitted to Food and Drug Administration Seeking Permission to Market Subdermal RFID VeriChip's Healthcare Applications in the United States
Wednesday October 29, 9:25 am ET
FDA Ruled Last October That VeriChip is a Regulated Medical Device "When Marketed to Provide Information to Assist in the Diagnosis or Treatment of Injury or Illness"
PALM BEACH, Fla.--(BUSINESS WIRE)--Oct. 29, 2003-- Applied Digital Solutions, Inc. (Nasdaq: ADSX - News) an advanced technology development company, announced today that a 510(k) application has been submitted to the United States Food and Drug Administration (FDA) seeking the agency's permission to market VeriChip's healthcare information applications in the United States.
About the size of a grain of rice, VeriChip(TM) is the world's first subdermal, radio frequency identification (RFID) microchip designed for human use in a variety of security, financial, emergency identification and, subject to FDA clearance, healthcare applications. Each VeriChip contains a unique verification number that is captured by briefly passing a proprietary scanner over the VeriChip. Once inserted just under the skin in a brief outpatient "chipping" procedure, the VeriChip is inconspicuous to the naked eye.
The detailed 510(k) submission was necessitated by the FDA's ruling last October that VeriChip is a regulated medical device "when marketed to provide information to assist in the diagnosis or treatment of injury or illness." In that same ruling, the FDA determined that VeriChip was not a regulated device for its "security, financial, and personal identification/safety applications."
In submitting the 510(k) application, frequently referred to as a "premarket notification submission," the Company is following the process outlined by an FDA representative at a public seminar about human implantable microchips at the National Academies in Washington, D.C., on November 15, 2002. During this seminar, the FDA official described a submission process for obtaining premarket clearance for safe and effective implantable microchips for human use.
Commenting on the 510(k) application and the regulatory review process ahead, Michael Krawitz, General Counsel of Applied Digital Solutions, said: "The specific approach outlined by the FDA involves submitting a 510(k) premarket application and, if necessary, a so-called draft Special Guidance to support 'de novo' review. Now that the 510(k) application has been submitted, the FDA will formally determine whether or not a predicate device has already been cleared by the FDA. If the FDA concludes that no such predicate device exists, the VeriChip application will be reviewed through the 'de novo' process to make a final determination regarding the clearance and categorization of VeriChip, as well as any specific regulatory requirements that may be necessary. While the timetable for all of this is not defined, we understand that the entire process could take several months or more to run its course."
Assuming clearance is obtained from the FDA, the Company plans to market VeriChip's family of innovative and potentially life-saving healthcare information applications in the United States using the VeriMed(TM) product name. VeriMed's many potential healthcare-related uses include the following:
Implanted medical device identification
Emergency access to patient-supplied health information
Portable medical records access
In-hospital patient identification
Medical facility connectivity via patient
Patient/therapy integration
Inter-facility patient identification
Disease/treatment management of at-risk populations (e.g. vaccination history)
About VeriChip(TM)
VeriChip is a subdermal, radio frequency identification (RFID) device that can be used in a variety of security, financial, emergency identification and other applications. About the size of a grain of rice, each VeriChip product contains a unique verification number that is captured by briefly passing a proprietary scanner over the VeriChip. The standard location of the microchip is in the triceps area between the elbow and the shoulder of the right arm. The brief outpatient "chipping" procedure lasts just a few minutes and involves only local anesthetic followed by quick, painless insertion of the VeriChip. Once inserted just under the skin, the VeriChip is inconspicuous to the naked eye. A small amount of radio frequency energy passes from the scanner energizing the dormant VeriChip, which then emits a radio frequency signal transmitting the verification number. In October 2002, the US Food and Drug Administration (FDA) ruled that VeriChip is not a regulated device with regard to its security, financial, personal identification/safety applications but that VeriChip's healthcare information applications are regulated by the FDA. VeriChip Corporation is a wholly owned subsidiary of Applied Digital Solutions (Nasdaq: ADSX - News). For more information about VeriChip, visit
www.adsx.com.
About Applied Digital Solutions, Inc.
Applied Digital Solutions is an advanced technology development company that focuses on a range of life-enhancing, personal safeguard technologies, early warning alert systems, miniaturized power sources and security monitoring systems combined with the comprehensive data management services required to support them. Through its Advanced Technology Group, the Company specializes in security-related data collection, value-added data intelligence and complex data delivery systems for a wide variety of end users including commercial operations, government agencies and consumers. Applied Digital Solutions owns a majority position in Digital Angel Corporation (AMEX: DOC - News). For more information, visit the Company's website at
www.adsx.com.
Statements about the Company's future expectations, including future revenues and earnings, and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and the Company's actual results could differ materially from expected results. The Company undertakes no obligation to update forward-looking statements to reflect subsequently occurring events or circumstances.
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