Industry News
The latest medical device regulatory news, clinical trials, and market insights
Critical Updates: Field Safety Notices Published Between 29 December 2025 and 2 January 2026
The UK Health Authorities have released an updated list of Field Safety Notices (FSNs) covering the period from 29 December…
Critical Update: Safety Correction Issued for Siemens Healthineers 3 Tesla MRI Systems
On January 11, 2026, the FDA published an urgent alert regarding a correction by Siemens Healthineers for certain 3 Tesla…
FDA Early Alert: Safety Risks Identified in Integra LifeSciences Convenience Kits
The U.S. Food and Drug Administration (FDA) issued an early alert regarding safety concerns with specific lots of Integra LifeSciences…
FDA Urges Immediate Recall of Draeger ErgoStar Catheter Mounts Over Safety Risks
The FDA has issued a critical announcement regarding the recall of certain Draeger ErgoStar Catheter Mounts. This action pertains to…
IMPRIS Imaging Issues Urgent Medical Device Correction for IMRIS Neuro III-SV Over Safety Risks
On October 13, 2025, IMPRIS Imaging Inc. initiated an urgent correction notice for its IMRIS Neuro III-SV models in response…
FDA Issues Critical Recall of Zenith Alpha 2 Thoracic Endovascular Graft by Cook Medical
Healthcare providers and clinical teams should be aware that the FDA has classified a recall of COOK MEDICAL's Zenith Alpha…
Critical Recall of FDA-Regulated Products by Gold Star Distribution Due to Severe Contamination Risks
Gold Star Distribution, Inc., has issued an urgent recall of various FDA-regulated products across three states. This notice pertains to…
Critical Software Correction Announced for Dexcom G6 and G6 Pro Devices
Dexcom Inc. recently issued an urgent correction for its Dexcom G6 Continuous Glucose Monitoring (CGM) System’s Android US CGM App,…
Critical Update: Revised Operational Instructions for GE HealthCare Carestation Anesthesia Systems
Healthcare professionals and facility management teams utilizing GE HealthCare’s Carestation 600 and 700 Series Anesthesia Systems should be aware of…
FDA Identifies Critical Update Needs for Abiomed’s Automated Impella Controllers
The Food and Drug Administration (FDA) has announced a critical update for the use of Automated Impella Controllers (AIC) by…
FDA Highlights Serious Recall of ICU Medical IV Gravity Burette Sets Due to Safety Risks
The FDA has announced a critical recall concerning ICU Medical Inc.’s IV Gravity Burette Sets, which are used for intravascular…
Singapore AI Startup i10X Lands $1M Pre-Seed to Accelerate Platform Growth
Meta description: Singapore-based AI aggregator i10X secures $1 million in pre-seed funding from notable early-stage investors to expand product and…