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A U.S. Court of Appeals for the Federal Circuit upheld the validity of two ArthroCare patents in an infringement lawsuit against devicemaker Smith & Nephew.
Seven hospital groups are urging the FDA to take action on its pledge to investigate and ultimately pursue a regulation requiring medical device manufacturers to bar code their devices.
Advocacy groups as well as the manufactures and suppliers of mobility assistive equipment (MAE) are expressing disappointment over new national coverage criteria implemented by the Centers for Medicare and Medicaid Services (CMS) regarding such equipment.
Three top-level executives voluntarily resigned from medical imaging company MedQuest Associates last month in the wake of a $40 million auditing error.
Johnson & Johnson (J&J) received approval from the Federal Trade Commission (FTC) to acquire Raleigh, N.C.-based Closure Medical, a maker of wound-healing products.
The FDA has issued a warning letter to General Electric (GE), citing the company’s Salt Lake City X-ray and fluoroscopic systems manufacturing facility with various violations of cGMP and quality systems regulations.
The FDA issued a final rule late last month to address the reclassification of a dental bone grafting product from Class III to Class II with special controls — a decision that paved the way for the reclassification of other dental bone grafting materials.
Now that drug-eluting stents (DESs) have proven their worth within the past year through high-profile clinical studies such as the REALITY trial, clinical investigators are focusing their energies on the effects of new stenting technologies in real-world patients.