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Physicians and patient advocates are calling on the FDA to make fundamental changes to how the agency addresses medical device malfunctions — specifically by better defining product recalls, by clarifying when physicians should be alerted to device problems, and by concentrating more resources on monitoring the manufacture of particularly “high-risk” products such as implantable cardioverter-defibrillators (ICDs).
AT&T next year will conduct 90-day customer trials of a managed end-to-end hosted radio-frequency identification (RFID) service, the telecommunications company said. AT&T will design, deploy and manage integrated, RFID applications that extend from its Internet protocol (IP) network and Internet data centers into the customers’ infrastructures, including RFID readers, edge devices and software, local area networks, firewalls and routers.
Rapidly evolving automatic identification technology may make the tracking of medical devices a more realistic goal than more traditional methods, and the FDA must recognize the newer tools' advantages, according to a white paper recently published by a nonprofit research agency.
Radio-frequency identification (RFID) technology’s cost and weaknesses, as well as regulatory hurdles, are holding down adoption levels in both the pharmaceutical industry and other sectors, experts said.
A recent study that found Cyberonics’ vagus nerve stimulator (VNS) system was effective in treating depression over a two-year period is under fire from a medical device watchdog group, which claims that the study is flawed.
The benefits of drug-coated stents don’t justify the increased cost over traditional bare-metal stents, according to a recent study that recommends the devices be restricted to patients in high-risk groups.
The FDA needs to recognize that rapidly evolving automatic identification technology may make the tracking of medical devices a more realistic goal, according to a white paper published by a nonprofit research agency.
Marking a development that helps further boost medical devicemaker St. Jude’s mounting implantable cardioverter-defibrillator (ICD) worldwide sales, the company announced Sept. 1 that it has received regulatory and reimbursement approvals from the Ministry of Health, Labor and Welfare in Japan for its Epic+ and Atlas+ implantable ICD product families.
The FDA has approved a new genetic test that its developers say will help doctors determine the correct drug dosage for individual patients while minimizing harmful drug reactions — a move that advances the much-anticipated advent of personalized medicine within the growing field of interventional diagnostics.
In the wake of last week’s FDA approval of Medtronic’s Guardian RT Continuous Glucose Monitoring System, the company has introduced two more products into the U.S. marketplace in what is turning out to be a busy month for the medical devicemaker.