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The agency determined that the risks posed by the OTC products were well established and premarket notification was not necessary to provide reasonable assurance of the product’s safety and effectiveness. Read More
The product is created with regenerated oxidized cellulose and designed to control bleeding and absorb exudate and drainage from superficial wounds. Read More
The company was awarded a grant of $1.4 million last December for clinical validation of the device by the European Fund for Regional Development. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
The system was designed to solve the problems experienced with the use of stiff metal screws that restrict normal joint motion and with flexible fixation… Read More