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The FDA said Oct. 13 it is alerting the public to counterfeit blood glucose test strips being sold in the U.S. for use with various models of LifeScan One Touch brand blood glucose monitors used by people with diabetes to measure their blood glucose.
Devicemakers can expect a slow approval process for devices that employ nanotechnology unless the FDA gets more funding to regulate the emerging field, experts say.
Bovie Medical, a maker of electrosurgical products, said Wednesday it entered an agreement to make a device that will be distributed and sold by Boston Scientific exclusively.
Epocal is pleased to announce receipt of 510(k) clearance from the US Food and Drug Administration to market its first product -- the EPOCTM Enterprise Point of Care Blood Analysis System -- in the United States.
Bovie Medical, a manufacturer and marketer of electrosurgical products, announced Oct. 12 it received FDA 510(k) clearance to market a new line of patent-pending advanced modular laparoscopic electrosurgical electrodes and a handle, aimed at the laparoscopic and arthroscopic markets.
Boston Scientific announced Oct. 12 that the U.S. Court of Appeals for the Federal Circuit sided with Guidant (now part of Boston Scientific) in a patent case against Medtronic.