Industry News
The latest medical device regulatory news, clinical trials, and market insights
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…
Critical Updates: Field Safety Notices for Medical Devices Issued from 5 to 9 May 2025
Medical device users and healthcare teams should note the publication of new Field Safety Notices (FSNs) from 5 to 9…
FDA Launches Guidance to Advance Non-Opioid Chronic Pain Solutions and Battle Opioid Misuse
The U.S. Food and Drug Administration (FDA) has announced a major step in addressing the opioid crisis by releasing draft…
Key Learnings from the 23rd IMDRF Workshop: Enhancing Post-Market Surveillance in Medical Device Regulation
On September 30, 2025, the International Medical Device Regulators Forum (IMDRF), together with DITTA and GMTA, published key findings from…
Critical Update: 3M Issues Urgent Labeling Correction for Ranger Blood and Fluid Warming Systems
The 3M Company has announced a critical correction for its Ranger Blood and Fluid Warming Systems, following discrepancies between labeled…
Important Regulatory Notification: Patient Safety Gaps Identified in Ipca Laboratories UK Ltd PILs
On September 30, 2025, Ipca Laboratories UK Ltd issued an urgent notification to the Medicines and Healthcare products Regulatory Agency…
U.S. Agencies Execute Record Seizure of Unauthorized E-Cigarettes Worth $86.5 Million
The U.S. Department of Health and Human Services (HHS) and U.S. Customs and Border Protection (CBP) announced on September 30,…
IMDRF Releases Progress Update on Strategic Plan 2021-2025
The International Medical Device Regulators Forum (IMDRF) has provided a detailed progress report on its Strategic Plan for 2021-2025. Released…
Critical FDA Warning: Olympus Initiates Recall of ViziShot 2 FLEX (19G) Needles Due to Safety Risks
On August 6, 2025, Olympus issued an urgent recall for specific lots of its ViziShot 2 FLEX (19G) Endobronchial Ultrasound…
Critical Updates on Medical Device Field Safety Notices Issued from 18 to 22 August 2025
Between 18 and 22 August 2025, several Field Safety Notices (FSNs) were issued for medical devices, alerting clinicians, regulatory staff,…
Stay Updated on IMDRF Developments: A New Way to Access Alerts
Attention clinical, quality, and regulatory professionals: the International Medical Device Regulators Forum (IMDRF) is making it easier for stakeholders to…
FDA Unveils Groundbreaking Dashboard for Real-Time Reporting of Cosmetic Product Adverse Events
On September 30, 2025, the U.S. Food and Drug Administration (FDA) introduced a new interactive tool, the FDA Adverse Event…