The FDA has announced a significant step in addressing emerging evidence regarding the use of acetaminophen…
Category: US
US / FDA updates on medical device regulation and quality.
Critical FDA Update: BD Expands Class I Recall for Alaris™ Pump Infusion Sets
Meta Description: BD has expanded its voluntary Class I recall for Alaris™ Pump infusion sets, adding…
FDA Lifts REMS for Caprelsa (vandetanib), Signaling New Safety Confidence
The U.S. Food and Drug Administration (FDA) has announced the removal of Risk Evaluation and Mitigation…
FDA Clears Innovative Essilor Stellest Eyeglass Lenses to Manage Pediatric Myopia Progression
The U.S. Food and Drug Administration (FDA) announced on September 29, 2025, the authorization of Essilor…
Olympus Recalls Specific ViziShot 2 FLEX Needles Due to Safety Concerns
Olympus Corporation has announced a voluntary global recall of certain lots of its ViziShot 2 FLEX…
FDA Approves First Pediatric Eyeglass Lenses to Mitigate Myopia Progression
The U.S. Food and Drug Administration (FDA) has authorized the marketing of Essilor Stellest eyeglass lenses.…