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Kensey Nash Corp. on Monday said it has received CE Mark approval for its QuickCat Extraction Catheter to sell the product throughout the European Union. The QuickCat Catheter is an aspiration catheter indicated for the removal of fresh soft emboli and thrombi from vessels in the arterial system.
The scope of a recent U.S. Department of Justice antitrust subpoena issued to orthopedic products company Stryker Corp. (SYK) has been "narrowed," Stryker's chief executive said.
Berlex, a U.S. affiliate of German company Schering AG, has initiated a nationwide U.S. recall of a single lot of an intravenous X-ray contrast agent, the FDA said July 20.
Cyberonics, Inc. announced that on July 20, 2006, the United States District Court for the Southern District of Texas dismissed the plaintiffs' consolidated complaint against the Company and certain of its officers and directors in the putative securities class action lawsuit styled In re Cyberonics, Inc. Securities Litigation, Civil Action H-05-2121, described in the Company's Form 10-Q filed with the Securities and Exchange Commission on March 6, 2006.
The FDA plans to strengthen its processes to ensure the integrity of advisory committee member selection and protect against potential conflicts of interest, the agency said July 24.
The Department of Justice (DOJ) and Medtronic announced July 18 the firm will pay the government $40 million to settle a civil suit alleging that the firm's Sofamor Danek division paid kickbacks to healthcare professionals to induce them to use Medtronic's spinal products.
The 64-slice CT scanner is a modern marvel creating vivid pictures of internal organs and blood vessels in less time than older diagnostic imaging machines.
Hutchinson Technology Incorporated announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin marketing its InSpectra StO2 Tissue Oxygenation Monitor.