DELRAY BEACH, Fla., July 29, 2015 (GLOBE NEWSWIRE) -- VeriTeQ Corporation (“VeriTeQ” or the “Company”) (OTC Markets:VTEQD), a provider of implantable medical device identification and radiation dose measurement technologies, announced today that the Food and Drug Administration (the “FDA”) has released draft guidance that names radio frequency identification (“RFID”) as a technology solution to comply with the direct part marking requirements of the FDA’s final rule for unique device identification of medical devices. VeriTeQ’s Q Inside Safety Technology™ is an FDA cleared implantable RFID microtransponder that can be used to identify implantable and reusable/reprocessable medical devices.
In 2013, the FDA released a final rule requiring a unique device identification system designed to adequately identify medical devices through distribution and use. In most cases, the final rule requires a unique device identifier (“UDI”) to be included on device labels and packages. In addition, the final rule states that a device that must bear a UDI on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. Although subject to change, the recent 2015 draft guidance states that acceptable methods to directly mark a device with a UDI include affixing a permanent tag such as an RFID tag to the device.
VeriTeQ’s FDA cleared Q Inside Safety Technology acts as an electronic serial number in breast implants and other implantable and reusable medical devices to provide physicians and patients with access to secure online databases to retrieve device-specific data, such as serial number, manufacturer name, date of manufacture, lot number, volume, size, and other data from the medical device manufacturer. Q Inside Safety Technology may also provide an extra level of protection to the patient in the event of a recall or other safety event.
Scott R. Silverman, Chairman and Chief Executive Officer of VeriTeQ, stated, “We are currently working with some of the leading breast implant manufacturers to help them understand that Q Inside Safety Technology not only helps them meet the FDA’s requirement for direct part marking of breast implant sizers and other reusable/reprocessable medical devices, but also offers added value through its ability to help provide long-term outcome data and other healthcare analytics. We also believe that our Q Inside Safety Technology can provide similar benefits to other medical device makers, including manufacturers of artificial joints and vascular ports.”
VeriTeQ 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 that are not purely historical facts, including statements about our beliefs, intentions or future expectations, may be "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 Securities Litigation Reform Act of 1995. Such forward-looking statements consist of any statement other than a recitation of historical fact and can be identified by the use of forward-looking terminology such as “may”, “expect”, “anticipate”, “intend”, “estimate” or the negative thereof or other variations thereof or comparable terminology. The reader is cautioned that all forward looking statements involve risks and uncertainties and are subject to change at any time, and that our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, VeriTeQ’s ability to continue to raise capital to fund its operations; VeriTeQ’s ability to successfully commercialize its Q Inside Safety Technology; as well as other risks or events beyond VeriTeQ’s control. Additional information about these and other factors may be described in VeriTeQ’s Form 10-K, filed on April 14, 2015. VeriTeQ 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.
Contact: VeriTeQ Allison Tomek, 561-846-7003 firstname.lastname@example.org