FDA Highlights Safety Alert for Abiomed’s Impella Controllers Due to Purge Retainer Issue
The FDA has issued an early alert regarding a significant safety concern with Abiomed’s Automated Impella Controllers. Clinical, quality, and […]
The FDA has issued an early alert regarding a significant safety concern with Abiomed’s Automated Impella Controllers. Clinical, quality, and […]
Medical device users and healthcare teams should note the publication of new Field Safety Notices (FSNs) from 5 to 9
The U.S. Food and Drug Administration (FDA) has announced a major step in addressing the opioid crisis by releasing draft
On September 30, 2025, the International Medical Device Regulators Forum (IMDRF), together with DITTA and GMTA, published key findings from
The 3M Company has announced a critical correction for its Ranger Blood and Fluid Warming Systems, following discrepancies between labeled
On September 30, 2025, Ipca Laboratories UK Ltd issued an urgent notification to the Medicines and Healthcare products Regulatory Agency
The U.S. Department of Health and Human Services (HHS) and U.S. Customs and Border Protection (CBP) announced on September 30,
The International Medical Device Regulators Forum (IMDRF) has provided a detailed progress report on its Strategic Plan for 2021-2025. Released
On August 6, 2025, Olympus issued an urgent recall for specific lots of its ViziShot 2 FLEX (19G) Endobronchial Ultrasound
Between 18 and 22 August 2025, several Field Safety Notices (FSNs) were issued for medical devices, alerting clinicians, regulatory staff,