Industry News
The latest medical device regulatory news, clinical trials, and market insights
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…
Essential MHRA Updates: August 2025 Safety Guidance for Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety advice for August 2025, addressing crucial updates…
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…
Review and Provide Feedback on IMDRF Regulatory Updates from the 24th Management Committee Session
The International Medical Device Regulators Forum (IMDRF) has announced updates from its Working Groups, which are now available for review…
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…
Medical Device Field Safety Notices: Updates from August 25–29, 2025
Field Safety Notices issued between August 25 and 29, 2025, provide crucial updates for stakeholders involved in medical device oversight.…
IMDRF’s Safety and Performance Workshop: Key Insights for Regulatory Professionals
The International Medical Device Regulators Forum (IMDRF) held a two-part workshop on September 11 and September 19, 2024, concentrating on…
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…
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,…
Profemur Modular Neck Hip Implants: Heightened Risk of Fractures and Revision Surgery Identified
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an important update regarding the risks associated with Profemur cobalt…
IMDRF Digitalizes Membership Applications: New Online Platform Launches
Clinical, quality, and regulatory teams take note: Starting May 2025, the International Medical Device Regulators Forum (IMDRF) is transitioning its…
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…