Regulators sign off on implantable tracking device to manage treatment of Alzheimer's, diabetes, heart disease, other conditions.
Applied Digital, maker of the implantable VeriChip for humans, announced Wednesday the FDA's approval of its technology for use in hospitals following a yearlong review by the agency.
The computer chips, which are about the size of a grain of rice, are designed to be injected into the fatty tissue of the arm. Using a special scanner, doctors and other hospital staff can fetch information from the chips, such as the patient's identity, their blood type and the details of their condition, in order to speed treatment.
The company is targeting the devices at patients suffering from Alzheimer's disease, diabetes, cardiovascular disease and other conditions requiring complex treatment.
Medical data is not stored on the devices, also known as radio frequency identification chips. Rather, it's stored in a database that links the chips' unique serial numbers with patient data. In its review, the FDA carefully studied the privacy issues around the technology, specifically the risk that medical records could be improperly disclosed, according to Applied Digital.
So far, no hospitals in the United States have placed orders for the chips, an Applied Digital representative said. So the company is planning to give away scanners, which cost $650 a piece, to 200 trauma centers around the country to jump-start the market.
The patient ID chips are taking off more quickly in other countries. In Mexico, more than 1,000 patients have been implanted with VeriChips. The Italian Ministry of Health is testing the technology in some hospitals there.
Applied Digital, based in Palm Beach, Fla., also markets the VeriChip as an authentication tool for use in building security and to complete financial transactions. The attorney general of Mexico and 200 people on his staff have already been implanted with the company's chips as part of an effort to control access to areas where confidential documents are kept.
The tags, which are inserted with a syringe, have been used to track pets and livestock for years, the company said.
Applied Digital has sold about 7,000 VeriChip devices, and approximately 1,000 have been inserted in humans, the company said in July. The company would not provide more current figures or disclose the price of the chips.