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Bausch & Lomb failed to submit a medical device report (MDR) detailing 35 serious injury reports of Fusarium keratitis -- the most common form of fungal keratitis, an infection of the cornea -- in contact lens wearers using the firm's ReNu with MoistureLoc product in Singapore, the FDA said in a Form 483 issued to the company May 15.
Two leading device associations say new initiatives proposed by the Centers for Medicare & Medicaid Services (CMS) will not accurately reflect appropriate payment for devices and will compromise innovation.
Thoratec Corporation a world leader in products to treat cardiovascular disease, today said that the FDA has approved an IDE (Investigational Device Exemption) supplement that allows enrollment of up to an additional 90 patients in the Bridge-to-Transplantation (BTT) arm of the company's HeartMate II Phase II trial under a Continued Access Protocol (CAP).
Stereotaxis, Inc. announced today the successful completion of a proof of concept demonstration of a magnetically enabled endocardial injection catheter developed in collaboration with Biologics Delivery Systems Group, Cordis Corporation.
Boston Scientific Corp. said it received approval from European regulators for the expanded use of its TAXUS Liberte coronary stent system in three new coronary procedures, which account for more than 20% of all coronary interventions.
St. Jude Medical, Inc. today announced U.S. Food and Drug Administration (FDA) approval of its newest devices for treating patients with potentially lethal heart arrhythmias
and heart failure.
Two major producers of heart devices, responding to a report by a medical group critical of industry's oversight of product safety, said yesterday that they planned to broaden how they conducted such reviews.
The U.S. Court of Appeals for the Federal Circuit has vacated a lower court ruling that U.S. Surgical did not infringe on a patent owned by Applied Medical, and sent the case back to the U.S. District Court for the Central District of California for review.
HHS' Office of Inspector General (OIG) has entered into a settlement agreement and corporate integrity agreement (CIA) with Lincare Holdings and its subsidiary Lincare, the agency has announced.