Essential Tools for Tracking Medical Device Recalls and Alerts
On September 30, 2025, the FDA spotlighted the resources designed to help medical device professionals stay informed about recalls, market…
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US / FDA updates on medical device regulation and quality.
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FDA Accelerates Approval of Forzinity: A Milestone for Barth Syndrome Treatment
The U.S. Food and Drug Administration (FDA) has taken a groundbreaking step by granting accelerated approval to Forzinity (elamipretide) injection…
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FDA Expands Early Alert Program for High-Risk Medical Device Recalls
On September 29, 2025, the FDA announced the expansion of its Early Alert program. This initiative is designed to improve…
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Critical FDA Advisory: Updated Performance Alerts for BD Alaris Infusion Sets
An updated communication from the FDA highlights significant concerns regarding BD Alaris Infusion Sets’ performance under particular use conditions. Clinical,…
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FDA Expands Access to Treatment Addressing Neurological Challenges in Autism
Meta description: The FDA has initiated approval for leucovorin calcium tablets to assist patients with cerebral folate deficiency, addressing autism-associated…
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Understanding Medical Device Recalls: What Healthcare Professionals Need to Know
Medical device recalls are critical actions taken to address potential safety or regulatory violations associated with a device. Recently, updates…
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FDA Reviews Risks: Acetaminophen in Pregnancy Linked to Autism Concerns
The FDA has announced a significant step in addressing emerging evidence regarding the use of acetaminophen (commonly known as Tylenol…
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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 15 discontinued models with…
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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 Strategies (REMS) for Caprelsa…
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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 Stellest eyeglass lenses. This…
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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 (19G) EBUS-TBNA needles. The…
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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. This marks the first…
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