UNIQUE DEVICE IDENTIFICATION (UDI)

VeriTeQ's "Q Inside Safety Technology" for Unique Device Identification (UDI) includes an FDA cleared, passive RFID microchip, proprietary hand-held reader and a database.

This technology enables manufacturers of reprocessed or reusable medical devices to comply with the direct part marking requirement of the FDA Final Rule for UDI. VeriTeQ's Q Inside Safety Technology reports the UDI of a medical device, in vivo, on demand, and at the point of care.

Implantable Medical Device Identification

VeriTeQ's Q Inside Safety Technology can also be used within implantable medical devices such as breast implants, vascular ports, and artificial joints, among others. Including Q Inside of implantable medical devices helps ensure rapid and accurate access to device data (i.e. serial number, lot number, batch number, etc.) which may be potentially lifesaving in the event of a product recall or when an adverse event report is issued by the FDA.

The FDA's UDI System also incorporates a Global Unique Device Identification Database (GUDID) which will be maintained by the FDA. One of the main principles of the FDA's GUDID is to ensure the safe use of medical devices and to allow for a more efficient corrective action should a medical device recall be necessary. The VeriTeQ UDI can safely and effectively identify medical devices within the body using an external reader in a matter of seconds.

All implantable medical device manufacturers include a product identification or warranty card in their packaging that is to be given to a patient after surgery. These cards are supposed to contain the name of the manufacturer and basic information about an implanted medical device (i.e. serial number, date and place of implantation, surgeon name, etc.). There are many issues with relying on a paper-based system to get access to implantable medical device data if and when needed. Patients often lose or misplace their product and/or warranty cards; therefore when they go back to the hospital or surgeon to try and obtain the data on their implanted medical devices, the data is not accessible. VeriTeQ Q Inside Safety Technology can never be lost as it is implanted in the medical device and can be accessed with VeriTeQ's proprietary hand held reader, on demand, at the point of care.

Currently, VeriTeQ has a relationship and supply agreement with one of the world's fastest growing manufacturers of vascular ports, which are commonly used in the administration of chemotherapy medications. The purpose of embedding VeriTeQ's Q Inside Safety Technology in a vascular port is to ensure the accurate device identification and medication dosage prior to treatment. This critical identification can prevent serious injury to the patient. VeriTeQ's goal is to create an industry standard among vascular port manufacturers whereby VeriTeQ's Q Inside Safety Technology becomes the identifier of choice for these important medical devices.

VeriTeQ also has a supply and development agreement with a global manufacturer of breast implants. VeriTeQ's technology is going to be used in the European Union, Asia and Latin America to provide a better device identification platform versus the paper-based system that is in place today.

A recent example highlighting the need for accurate device identification occurred in 2010, when a France-based manufacturer of breast implants named PIP, was shut down due to the fact that the company used industrial grade silicone in their implants instead of medical-grade silicone. Unfortunately, it was found that PIP implants had double the rupture rate of other implants, and as news of leaks spread, breast implant patients grew very concerned that they may have had PIP's implants inside of their bodies. Many of these patients did not have their product or warranty cards and their plastic surgeons and surgical centers did not have records about which implants were inside each patient. This uncertainty lead to unnecessary panic among patients as well as breast implant manufacturers.

Implementation of VeriTeQ's Q Inside Safety Technology system can help provide peace of mind to patients, device manufacturers, healthcare providers, risk managers and regulatory authorities.

Unique Device Identification (UDI)

VeriTeQ’s Unique Device Identification Technology, the World’s first and only implantable RFID technology cleared for use by the FDA.

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Dosimeter Technologies

FDA cleared and CE Marked Radiation Dosimeter Technologies that measure and record the dose of radiation that a patient receives during treatment.

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Informatics & Data Analytics

VeriTeQ is helping to create the future of evidence based medicine, using device and treatment data collected at the point of care via its UDI and dosimeter technologies.

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Future Applications

VeriTeQ is creating new applications in bio-sensing and bio-technologies.

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