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 U.S. Food and Drug Administration (“FDA”) has released
its Final Rule for Unique Device Identification (“UDI”).
The Final Rule for UDI requires all medical devices distributed in the
U.S. that are intended to be used more than once and intended to undergo
any form of reprocessing before each use to carry a UDI. The FDA Rule
was issued in response to the passage of the FDA Safety and Innovation
Act, which directed the federal agency to develop regulations that would
create a UDI system for medical devices. Prior to the finalization of
the FDA Final Rule, the FDA published a Proposed Rule, which included a
requirement that all implantable medical devices have a “direct part
marking” on the device itself rather than just labeling of disposable
packaging. The direct part marking mandate for all medical devices that
are implantable was revised in the FDA Final Rule to include only
medical devices that are reprocessed.
Based on the Final Rule and existing relationships the Company has
established with breast implant and vascular port manufacturers to
identify those devices through VeriTeQ’s Q Inside Safety Technology, the
Company believes it is well positioned to continue its market
penetration within those categories. Furthermore, the Company believes
that the changes to the Final Rule open new potential business lines in
reusable or reprocessed medical devices in addition to the business
opportunity in implantable medical devices.
“We believe the FDA Proposed Rule included identification of both
reusable and non-reusable implantable medical devices because such
identification offers an added level of patient safety and accurate
device identification at the point of care or in the event of a recall,
and that remains the case,” stated Scott R. Silverman, Chairman and
Chief Executive Officer of VeriTeQ. “Although the FDA is not requiring
manufacturers to offer non-reusable implantable devices with unique
identification direct part marking, we believe prudent manufacturers
will do so, patient advocacy groups will demand it, and the inevitable
product litigation will make it financially practical.”
VeriTeQ’s Q Inside Safety Technology is an FDA cleared radio frequency
identification microchip that can be used to identify an implanted
medical device from outside of the body with a handheld reader.
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 FDA cleared RFID microchip
technology that can be 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 VeriTeQ is well
positioned to continue its market penetration within breast implant and
vascular port manufacturers; the likelihood that the changes to
the Final Rule open new potential business lines in reusable or
reprocessed medical devices in addition to the business opportunity in
implantable medical devices; the likelihood that prudent manufacturers
will offer non-reusable implantable devices with unique identification
direct part marking, patient advocacy groups will demand it, and the
inevitable product litigation will make it financially practical;
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 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.
Copyright Business Wire 2013