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FDA
Applied Digital Updates Shareholders on the Status of the 510-K-
Application for the Medical Use of Verichip
DELRAY BEACH, Fla. & SO. ST. PAUL, Minn.
CEOcast, Inc. for Applied Digital
Ken Sgro, 212-732-4300
ksgro@ceocast.com
or
Allen & Caron Inc. for Digital Angel Corporation
Investors:
Mike Lucarelli, 212-691-8087,
m.lucarelli@allencaron.com,
or
Media:
Len Hall, 949-474-4300
len@allencaron.com
Applied Digital (NASDAQ:ADSX) As expected, the FDA has issued a letter indicating that there is no substantially equivalent device and, accordingly, a "de novo" application will immediately be filed
Applied Digital (NASDAQ:ADSX), a provider of innovative security products, announced today that Digital Angel Corporation (AMEX
OC) has received notice from the U.S. Food and Drug Administration (FDA) stating that there is no substantially equivalent device to VeriChip currently being marketed. Accordingly, the Company will immediately file a "de novo" application for VeriChip's medical uses. Statutory guidelines provide up to 60 days for the de novo review process. Digital Angel is the manufacturer of VeriChip and has licensed the technology to VeriChip Corporation, a wholly-owned subsidiary of Applied Digital, for human applications.
"We are pleased that the FDA has issued this ruling," said Scott R. Silverman, Applied Digital's Chairman and CEO. "While we certainly would have preferred this to happen sooner, we are pleased that the FDA has made this determination. This assures the Company that the FDA will determine, in a relatively short period of time, whether we can introduce the VeriChip to the health care market in the United States. As we expected this outcome, we have already prepared our de novo application and will file it immediately."
As previously disclosed, the FDA response is the long-expected result of the Companies' 510 (K) application for the medical application of VeriChip, originally filed in October 2003.
VeriChip is the world's first implantable microchip designed for human use. Digital Angel Corporation filed the 510(K) application with the FDA in October 2003 on behalf of VeriChip seeking the agency's approval to market VeriChip's healthcare information applications in the United States.
Commenting of this expected pathway, Kevin McGrath, CEO of Digital Angel Corporation stated, "We have been preparing for this day for many months. We look forward to working with the FDA to expedite its decision-making process."
Commenting on the medical application of VeriChip, Kevin Wiley, CEO of VeriChip Corporation, stated, "We continue to market and sell VeriChip internationally primarily for the security application. As evidenced by the recent chipping of Mexico's Attorney General and his staff, the VeriChip technology provides first-of-a-kind tamper-proof and secure applications. These applications can also occur with medical records and medical device information. We look forward to the de novo process and the ultimate conclusion of the regulatory process."
About the size of a grain of rice, VeriChip is a subdermal radio frequency (RFID) microchip. Once inserted under the skin in a brief outpatient procedure, the human eye cannot see VeriChip. Each VeriChip contains a unique verification number that is captured by briefly passing a proprietary scanner over the chipping site.
In addition to healthcare applications, VeriChip can be used in a variety of security, financial and emergency identification applications. The healthcare application is the only one subject to FDA clearance.