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.
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The system uses AI-powered tools to speed up workflows and is designed to handle complex cardiac cases.
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A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
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HTM leaders are building new programs and pipelines to sustain teams amid mounting workforce shortages.
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The Transcend Plus update for EPIQ CVx and Affiniti CVx systems includes new FDA-cleared AI applications and image quality enhancements designed to improve diagnostic confidence and streamline clinical workflows.
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