VeriTeQ's Patented and FDA Cleared Technology Can Help Medical Device Manufacturers Comply with FDA
VeriTeQ's Patented and FDA Cleared Technology Can Help Medical Device Manufacturers Comply with FDA Proposed Rule for Unique Device Identification - Direct Mark Requirement
VeriTeQ radio frequency identification microchip, "Q Inside," can be used within implantable devices to identify them from outside the body
Company to host conference call today at 4:15 pm to discuss the Company's new direction - updated information provided below
DELRAY BEACH, Fla.--(BUSINESS WIRE)-- Digital Angel Corporation ("Digital Angel" or the "Company") (OTC Markets: DIGA), a provider of implantable medical device identification and radiation dose measurement technologies following its recent share exchange with VeriTeQ Acquisition Corporation ("VeriTeQ"), announced today that the patented VeriTeQ "Q Inside" radio frequency identification ("RFID") microchip, cleared by the U.S. Food and Drug Administration ("FDA"), can help implantable medical device manufacturers comply with the FDA's Proposed Rule for Unique Device Identification ("UDI") - Direct Mark requirement.
The FDA's Proposed Rule for UDI reflects in § 801.50 a direct marking requirement recommended for implantable medical devices because these devices present unique risks that would be better controlled through such a direct marking (versus simple labeling on the outside of the medical device packaging). The Company believes that its VeriTeQ microchip, "Q Inside," is the only proven direct mark technology of its kind that provides Automatic Identification and Data Capture (AIDC) technology as required for implantable medical devices under the FDA's Proposed Rule. The UDI Regulation has been released from the FDA to the White House Office of Management and Budget, and the final review is currently underway. It is anticipated that the UDI Regulation is scheduled to be released very soon.
"We believe we are uniquely positioned with our FDA cleared technology and have an early mover advantage to give major medical device manufacturers the ability to comply with the direct mark requirement of FDA's Proposed Rule," stated Scott R. Silverman, Chairman and CEO of Digital Angel. "More importantly, however, our "Q Inside" technology not only can help device manufacturers, but ultimately can enable a patient's healthcare team to have accurate and timely access to data about an implantable medical device, in vivo, on demand, in the event of a recall or other safety event. We are not aware of any other currently available and proven technology that has this ability."
VeriTeQ has a broad intellectual property portfolio that includes more than 100 patents issued, patents pending, and patent licenses. VeriTeQ's core technologies are FDA Cleared and CE marked, which is a key indicator of a product's compliance with legislation in the European Union.
On July 9, 2012, the FDA Safety and Innovation Act was signed into law. In conjunction with that legislation, the FDA proposed a new rule for a UDI System, which would, among other things, allow more accurate reporting of adverse event reports so that problem devices can be identified and corrected more quickly; reduce medical errors by enabling health care professionals to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device; provide a consistent way to enter information about devices in electronic health records and clinical information systems; provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls; and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
Updated Conference Call Information
As previously announced, the Company will host a conference call today at 4:15 p.m. ET to discuss the transaction and the Company's business. Please note that the call-in information has changed. Interested participants should call (877) 375-4189 and use passcode 19476903. For people unable to participate in the conference call, a digital recording will be available two hours after the call's completion until July 22, 2013. To access the recording, please dial (855) 859-2056 and use passcode 19476903.
About Digital Angel and VeriTeQ
Digital Angel, through its VeriTeQ wholly owned subsidiary, develops innovative, proprietary RFID technologies for implantable medical device identification, and dosimeter technologies for use in radiation therapy treatment. VeriTeQ offers the world's first and only implantable RFID technology used to identify implantable medical devices, in vivo, on demand, at the point of care. VeriTeQ's dosimeters provide patient safety mechanisms while measuring and recording the dose of radiation delivered to a patient in real time. For more information on VeriTeQ, please visit www.veriteqcorp.com.
Statements in this press release about our future expectations, including without limitation, the likelihood that the VeriTeQ "Q Inside" RFID microchip can help implantable medical device manufacturers comply with the FDA's Proposed Rule for UDI; the likelihood that FDA's final rule is expected to be released very soon; the likelihood that the VeriTeQ direct mark technology can enable a patient's healthcare team to have accurate and timely access to data about an implantable medical device, in vivo, on demand, in the event of a recall or other safety event; constitute "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 our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, the ability to promptly and effectively integrate the businesses of Digital Angel and VeriTeQ; VeriTeQ's ability to target the UDI sector and implantable medical device manufacturers; VeriTeQ's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in future filings with the Securities and Exchange Commission The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
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