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GE OEC Medical Systems, its parent company, General Electric -- doing business as GE Healthcare -- and two of their top executives have signed a consent decree of permanent injunction related to X-ray surgical imaging systems, the FDA announced.
Because all FDA centers and various regulations are involved with combination products, whatever is happening with them will have an impact on all other products, Mason Diamond, vice president of clinical and regulatory affairs for TyRx Pharma, said.
Digene filed a complaint for patent infringement against Third Wave Technologies in the U.S. District Court for the Western District of Wisconsin, Digene said in a Jan. 11 filing.
An FDA program that encourages eligible device firms to pay accredited organizations to conduct their inspections rather than having the FDA conduct inspections for free may work better for larger firms than smaller ones, according to a new report.
Innogenetics announced last week that the U.S. District Court for the Western District of Wisconsin entered a permanent injunction against Abbott Laboratories, enjoining Abbott from any further sales or use of products, including components, that infringe on Innogenetics' patented hepatitis C genotyping technology.
The awaited implantable cardioverter-defibrillator (ICD) market recovery "is now afoot," Lazard Capital Markets analyst Alexander Arrow said in a Jan. 8 research note.
Skytron violated current good manufacturing practices and lacked adequate standards for complaint reviews, making its surgical beds adulterated and misbranded, an FDA warning letter said.
Genzyme said this week its OSOM Trichomonas Rapid Test has a new, specific current procedural terminology (CPT) code, which will allow for easier reimbursement.
The FDA is withdrawing a direct final rule that would have amended the classification regulations for reprocessed single-use devices (SUDs) due to adverse event comments it received following the rule's publication Sept. 25, 2006.