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Following a rash of infections related to duodenoscopes, the FDA has given its blessing to Fujifilm Medical Systems’ updated manual reprocessing instructions for its ED-530XT model. Read More
CrystalBraces has received an FDA warning letter for failing to adhere to several procedural and validation requirements for a dental aligner. Read More
ECRI Institute is raising safety concerns associated with medical devices ranging from flexible endoscopes to ventilators, calling for an increased awareness of hazards that the products pose to patients. Read More
A Senate report that followed an investigation by Sen. Patty Murray’s (D-Wash.) office has found that the FDA’s regulatory system for monitoring the safety of devices failed to quickly identify and resolve the spread of antibiotic-resistant infections linked to duodenoscopes. Read More