FDAnews Device Daily Bulletin
Sept. 19, 2012 | Vol. 9 No. 184
Building on the enhanced tracking abilities that will be created by implementation of unique device identifiers (UDI), the FDA plans to begin rolling out by year’s end an enhanced postmarket surveillance program for medical devices.
Device approvals may take longer in the U.S. than in the EU — but the fact that U.S. insurers are quicker to pay for new technologies means patients benefit from new devices at roughly the same speed in both places, a new study suggests.
Meridian Bioscience said its test to detect a common bacterial throat infection received marketing approval in the United States.
David Washington has encountered a hurdle to getting the medical treatment he needs to return to work as a mechanic: He can’t find an imaging device large enough to accommodate his 630 pounds.
Saint Louis University sued a Medtronic subsidiary in Missouri federal court for allegedly shortchanging the university of more than $7 million in royalty payments for surgical navigation technology products, saying the total damages could be significantly more.
Codman & Shutleff has seen positive results of its Vascular Reconstruction Device , a self-expanding stent used in patients with wide neck saccular aneurysms.
Medtronic is looking for a pharmaceutical company to partner with on its new pump technology for treating Alzheimer patients.
BioFire Diagnostics, a Utah company that develops and manufacturers instruments to identify pathogens, will receive a tax credit worth up to $24.4 million over the next 20 years conditioned upon it creating up to 657 jobs.
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