Digital Angel Corp., also known as VeriTeQ, a provider of implantable medical device identification and radiation dose measurement technologies following its recent share exchange with VeriTeQ Acquisition Corp. ("VeriTeQ"), announced that it has hired Caryn Mills as its Director of Strategic Alliances for its Unique Device Identification ("UDI") business.
In a release, the company noted that Mills will be responsible for identifying and advancing new partnerships with implantable medical device manufacturers to help them meet federal regulations requiring unique device identification by using the Company's FDA cleared radio frequency identification microchip, "Q Inside," within their devices.
Mills has over 15 years of successful sales, marketing and customer relations expertise, most of which comes from the medical device and pharmaceutical industries, including companies such as Covidien Surgical Solutions and Schering Plough Corp.
"The FDA's Proposed Rule requiring the UDI of all implantable medical devices makes this is an opportune time to join VeriTeQ," said Mills. "I am eager to utilize my industry experience to advance the use of VeriTeQ's innovative and first-of-its-kind Q Inside technology, which enables the safe and accurate identification of implantable medical devices from outside of the body."
"Caryn's solid background and relationships in the medical device industry make her a valuable addition to our team," said Scott R. Silverman, Chairman and Chief Executive Officer of VeriTeQ. "We believe Caryn's expertise will enable her to take advantage of the substantial opportunities in the industry due to the FDA's Proposed Rule for UDI of implantable medical devices."
Q Inside provides a way for implantable medical device manufacturers to comply with the FDA's direct marking requirement of the Proposed Rule for UDI. 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 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 final UDI Regulation will be released in the near future.
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; reduce medical errors by enabling health care professionals to precisely identify a device and obtain 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.
Digital Angel, through its VeriTeQ subsidiary, develops proprietary RFID technologies for implantable medical device identification, and dosimeter technologies for use in radiation therapy treatment.
((Comments on this story may be sent to email@example.com))