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.
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.
The FDA’s focus on encouraging devicemakers who want to market Class III devices that could benefit patients with rare diseases or conditions has led to the humanitarian device exemption (HDE) for these very small markets.
The FDA is requiring that labeling for all food allergen skin diagnostic tests be updated to contain a warning of false negative results and potential life-threatening anaphylaxis from subsequent allergen exposure.
The FDA has cleared the Abbott FreeStyle Libre 2 and FreeStyle Libre3 continuous glucose monitoring (CGM) sensors to be integrated with automated insulin delivery systems (AID) which automatically adjusts and administers insulin based on real-time blood glucose data.