FDAnews Device Daily Bulletin
June 5, 2012 | Vol. 9 No. 110
The House voted 387-5 Wednesday evening to pass an omnibus FDA user fee bill, giving lawmakers most of June to iron out differences between that measure and one the Senate passed May 24.
Device companies will continue to develop products abroad as long as financial and regulatory conditions overseas are more favorable than in the U.S., warned experts at the Food & Drug Law Institute annual meeting in Washington, D.C.
The FDA, the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health and the Occupational Safety and Health Administration are promoting the use of blunt-tip surgical suture needles to lower the chance of needle-stick injuries and prevent the spread of blood-related diseases among surgical personnel.
The U.S. Food and Drug Administration “does not have the power under current law to require device makers to prove they have fixed design flaws when they want to sell a new device based on one that has been recalled by manufacturers for safety problems.”
Medtronic has been on a quest to develop such a device: a small, portable closed-loop system comprising a continuous glucose monitor, an insulin pump capable of delivering precise amounts of insulin and a computer algorithm to tell the pump how much insulin to deliver based on blood sugar levels.
French devicemaker Medicrea touted FDA approval for its LigaPass spinal fixation system, which uses a rod and strap system to connect vertebrae without using pedicle screws or hooks.
GE Healthcare signed an agreement with Affibody AB to collaborate on the development of a Her2-targeted PET imaging agent, which is scheduled to begin clinical trials later this year.
Regulatory filings show Seventh Sense Biosystems has raised $200,000 in its latest round of debt funding.
Cook Medical said that it has joined a coalition that wants Congress to repeal a legislative measure that would impose excise taxes on its industry.
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