Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
Despite a 115% increase in FDA recalls since 2018, MasterControl found that medical devices only contributed 4% of the total number.
Researchers designed medical devices that could be used inside the body then safely broken down on demand when they’re no longer needed.
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
Ambu has donated 650 of its resuscitators to the International Medical Corps as part of the celebration of the device’s 65th birthday.
Read MoreVizient released its latest Medical Device Tech Watch identifying trends in AI, examining treatment options for pulmonary embolism, and more.
Read MoreCurrently valued at $14.9 billion, the global anesthesia devices market is slated to exhibit a compound annual growth rate of 7.6% by 2030.
Read MoreInvictus Medical has submitted a De Novo application to the FDA for its Neoasis incubator-based active noise control device.
Read MoreIndustry experts predict medical device organizations will be able to effectively carry on amid any potential future economic turmoil.
Read MoreMedWand’s telemedicine device and VirtualCare ecosystem are commercially available to better help enable clinical exams.
Read MoreSmiths Medical had notified customers of a potential issue with specific Level 1Â H-2 Pressure Chambers used with Level 1 Fast Flow Fluid Warmers.