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Nearly 70 percent of device manufacturers say the FDA's Medical Device User Fee and Modernization Act of 2002 (MDUFMA) has not improved the predictability or timeliness of device reviews, according to a survey conducted by the Lewin Group for the FDA.
Beckman Coulter, Inc. along with Applera Corporation announced that they have established the terms of a settlement to resolve all outstanding legal disputes between the parties relating to claims of certain Beckman Coulter patents and Applera's allegations of breach of contract with respect to certain licensed technology.
For the second year in a row, Abbott Laboratories' shareholders April 28 resoundingly defeated shareholder proposals that would have forced the drug and device maker to disclose more information about political donations, divide the chief executive and chairman roles and tie executive pay to a performance standard.
Tulip BioMed, Inc., formerly known as Cell Bio-Systems, Inc., a developer of medical devices and patented technologies for the living tissue markets, including plastic, cosmetic, and orthopedic surgeries, today announced it has launched sales of its new disposable surgical instruments for the removal of soft tissue and fluid for the plastic surgery market after receiving U.S. Food and Drug Administration (FDA) 510(k) clearance for its cannula devices.
The US Food and Drug Administration (FDA) has approved a liquid-based Papanicolaou test system for use in collecting and preparing cervical/vaginal specimens; a continuous monitoring system for detecting trends and tracking glucose level patterns in adults with diabetes mellitus; and a bioabsorbable coated mesh for use in the surgical repair and reinforcement of soft tissue.
The Heart Rhythm Society (HRS) has issued a series of recommendations for industry, the FDA and physicians to consider
in revising the processes for postmarket surveillance and analysis of pacemakers and implantable cardioverter-defibrillators (ICDs).