Articles Tagged with ''Technology''

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The poor understanding of device performance in magnetic resonance imaging (MRI) environments means that implantable devices "remain contraindicated for use with MRI," Biophan Technologies Vice President of Engineering Jeffrey Helfer said Jan. 8.

VaxGen said that HHS has terminated for default the company’s $877.5 million contract to provide 75 million doses of a modern anthrax vaccine for civilian biodefense.

A UK-based consortium of companies is developing an implantable microgenerator to convert energy from human body movement, including joint movement and heartbeats, into power for implanted medical devices such as pacemakers, electrical stimulators and instrumented joints.

IBM has announced a new product that it says gives clients the ability to securely share and analyze real-time data stored on radiofrequency identification (RFID) tags, which are increasingly used for drug authentication.

The quality systems approach is as essential when making changes to pharmaceutical and medical device industry software as it is when changes are made to other aspects of the manufacturing process, experts said at a recent conference.

Industry experts speaking at an FDA public hearing voiced their support for the agency’s all-electronic submission system proposal, but warned that the agency has a lot to consider before going forward.

The FDA’s long-awaited revision of Part 11, which is now slated for release this year, will impose major new burdens on industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official.

IBM has announced a new product that it says gives clients the ability to securely share and analyze real-time data stored on radiofrequency identification (RFID) tags, which are increasingly used for drug authentication.

The quality systems approach is as essential when making changes to pharmaceutical and medical device industry software as it is when changes are made to other aspects of the manufacturing process, experts said at a recent conference.

Industry experts speaking at an FDA public hearing voiced their support for the agency’s all-electronic submission system proposal, but warned that the agency has a lot to consider before going forward.