Digital Angel Corporation, a provider of implantable medical device identification and radiation dose measurement technologies following its recent share exchange with VeriTeQ Acquisition Corporation, announced that Establishment Labs, S.A. (“EL”), d/b/a Motiva, is now ready to market the world’s first traceable breast implant with Q Inside, enabling a manufacturer, physician or patient to access a secure online database and retrieve implant-specific data such as serial number, manufacturer name, date of manufacture, lot number, volume, size, and other data. In September 2012, VeriTeQ entered into a development and supply agreement with EL, a global provider of breast implants under the Motiva Implant Matrix® brand name, to build next-generation breast implants that contain VeriTeQ’s Unique Device Identifier (“UDI”) called “Q Inside.” “With our FDA cleared Q Inside technology, we believe we offer the only solution of its kind that is currently available to meet the FDA’s Proposed Rule for the unique device identification of implantable medical devices,” stated Scott R. Silverman, Chairman and Chief Executive Officer of Digital Angel. “We are very pleased to work with EL, an innovative company with a forward-thinking management team on the cutting edge of healthcare technology.” 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.
VeriTeQ’s Q Inside, a passive radio frequency identification (“RFID”) microchip, enables implantable medical devices to be quickly and safely identified from outside the body. Q Inside is a direct marking technology that provides Automatic Identification and Data Capture technology as required for implantable medical devices under the FDA’s Proposed Rule for UDI.
According to the International Society of Aesthetic Plastic Surgery, the number of breast augmentation procedures performed worldwide in 2011 exceeded 1.2 million.