FDA Clears VeriChip for Medical Applications in the United States
TMC Net | October 13 2004
DELRAY BEACH, Fla. & SOUTH ST. PAUL, Minn. --(Business Wire)-- Oct. 13, 2004 -- Applied Digital (NASDAQ: ADSX), a provider of Security Through Innovation(TM) and Digital Angel Corporation (AMEX:DOC) announced today that VeriChip(TM), the world's first implantable radio frequency identification (RFID) microchip for human use, has been cleared by the U.S. Food and Drug Administration (FDA) for medical uses in the United States. The FDA clearance follows the completion of a de novo application review.
The Company will hold a conference call today at 10:30 am eastern time in order to discuss the FDA's decision, Company's marketing strategy and medical applications for VeriChip. Interested participants should dial (800) 472-9309. The conference ID is 1531948. International callers should dial (706) 643-9561 and use the same conference ID. The call will also be webcast and will be available on the Home Page of Applied Digital's web site at www.adsx.com.
As previously disclosed, the FDA response is the result of the Company's 510(k) application and subsequent de novo application for the medical and healthcare uses of VeriChip, originally submitted in October 2003. Digital Angel Corporation is the manufacturer of VeriChip and has licensed the technology to VeriChip Corporation, a wholly owned subsidiary of Applied Digital, for human applications.
The VeriChip Health Information Microtransponder System consists of an implantable RFID microtransponder, an inserter, a proprietary hand-held scanner, and secure database containing the patient approved healthcare information. About the size of a grain of rice, VeriChip is a subdermal radio frequency microchip. Once inserted under the skin in a brief outpatient procedure, the VeriChip cannot be seen by the human eye. Each VeriChip contains a unique 16-digit verification number that is captured by briefly passing a proprietary scanner over the insertion site. The captured 16 digit number links to the database via encrypted Internet access. The previously stored information is then conveyed via the internet to the registered requesting healthcare provider.