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The FDA July 18 provided an explanation of the safety concerns of its Ophthalmic Devices Panel in recommending against approval for VisionCare's Implantable Miniature Telescope (IMT).
The Department of Justice (DOJ) and Medtronic announced July 18 the firm will pay the government $40 million to settle civil allegations the firm's Sofamor Danek division paid kickbacks to healthcare professionals (HCPs) inducing them to use Medtronic's spinal products.
The FDA recently received comments on its "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials -- Draft Guidance for Industry and FDA Staff," issued May 23.
Antares Pharma, Inc., announced having signed an agreement with Teva Pharmaceutical Industries Ltd. for the development and supply of a new Antares disposable injection device.
Organon announced that the U.S. Food and Drug Administration (FDA) approved IMPLANON (etonogestrel implant) 68mg, the first and only single-rod implantable contraceptive that is effective for up to three years.
Utah-based Innovasis, a research, development and manufacturer of spinal implant devices, has received 510(k) clearance of the Opteryx Cervical Plate System by the United States Food and Drug Administration.
After six weeks of testimony, a jury will now decide the merits of Kinetic Concepts Inc.'s patent infringement lawsuit against competitor BlueSky Medical Corp. and Swiss company Madela AG.
Baxa Corporation, a Colorado manufacturer of medical devices for health-system pharmacies, was selected as one of '50 Companies to Watch' by Medical Device and Diagnostic Industry in its review of the medical device industry.
St. Jude Medical announced U.S. Food and Drug Administration (FDA) approval of new, powerful devices for treating patients with potentially lethal heart arrhythmias and heart failure.