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The Council of the European Union voted on Tuesday to adopt the proposal from its Commission for Health and Food Safety to delay implementation of the EU Medical Device Regulation.
The FDA updated its Sept. 8, 2022, safety communication to report on 19 published cases of squamous cell carcinoma (SCC) skin cancer and various lymphomas in the capsule that forms around breast implants, three of which were reported to result in patient deaths.
The FDA says more testing and analysis is needed to determine the risk of exposure to toxic compounds from tubing used in any hemodialysis or peritoneal dialysis system that has parts made of chlorinated peroxide cured silicone.
Dominion Aesthetics Technologies, maker of Eon, a fat-reducing laser device, received a Form 483 following a September 2022 inspection of its Winter Park, Fla., facility for failure to properly handle complaints, to establish procedures for corrective and preventive action (CAPA) and to follow procedure for design control, among other lapses.
The FDA has granted de novo approval to Neuromod’s Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.
Abbott’s newly FDA-cleared blood test is the first commercially available diagnostic that assesses whether a patient with a mild traumatic brain injury (mTBI) — commonly known as a concussion — needs further evaluation with a computed tomography (CT) scan.