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The company said its Biocell saline- and silicone-filled breast implants and tissue expanders will no longer be available in any market they’re currently cleared for, and healthcare providers should no longer use them. Read More
The company said its panel covers 50 diagnostic targets with 30 assays and delivers microorganism and resistance marker results in approximately five hours. Read More
On July 11, Amgen won an injunction against Praluent in a German court and the company’s attorneys have referenced that injunction in their U.S. court filing. Read More
The guidance includes an updated manufacturer incident report (MIR) form that will be required for devices certified under MDD in January 2020. Read More