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Latest From Elizabeth Orr
A newly approved contact lens from CooperVision promises to slow the progression of nearsightedness when prescribed to children aged 8 to 12.
FDA Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices
US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in dental amalgam at a 13-14 November agency advisory committee meeting. The get-together was held to determine what additional actions the FDA can take to make sure certain patients are protected from immunological risks of the implants. The panel ultimately backed a transition away from mercury amalgam dental fillings and pushed for more research into risks associated with metal implants.
Research investigating outcomes in patients treated with paclitaxel-coated devices demonstrated a consistent if modest mortality signal when compared to bare-metal stents. However, the signal was not seen in real-world data, and some researchers question whether the signal might stem from problems in the original trials.
Zimmer Biomet has issued a recall on its ROSA Brain 3.0 software platform due to a software issue that could cause patient injury.
An ongoing trial of Medtronic’s In.Pact Admiral paclitaxel-coated balloon found a four-year survival rate in line with what would be expected for the patient population and a relatively low rate of complications.
The US FDA released two device-related close-out letters in October.